Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
If necessary, customers should use the telephone 0800-26-4848 or the email contato@sa.biomerieux.com to get in touch with Biomerieux Brasil SA. Anvisa's Technovigilance Unit is monitoring this case.
Cause
The manufacturer company verified that some strains of the acinetobacter baumannii microorganism present "sensitive" final results for the susceptibility test carried out on the vitek 2 xl and vitek 2 compact systems, against the antibiotic amicacin; in the presence of reference methods, such strains present "resistant" final results.
Action
The company Biomerieux Brasil SA has informed that it has sent letters of communication to the clients involved, instructing the users of the cited products to carry out alternative methodology before releasing the result (s) of susceptibility test (s) antibiotic / antigen ratio Amicacin x Acinetobacter baumannii.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Abbott Vascular is initiating a voluntary Field Safety Corrective Action for the HT Connect Guide Wires peripheral wire family because a small number of devices present a partial lamination of the PTFE coating. To date, the frequency of reported incidents was 0.08%. Although no long-term or irreversible effects have been reported in patients, the potential risks associated with coating lamination include: embolism, thrombus and occlusion of the peripheral veins. Abbott Vascular research is underway and there is no definite root cause identified for inadequate adhesion of PTFE coating to some guidewires. During continued research, Abbott Vascular is identifying improvements in the coating process to ensure adhesion of PTFE coating. As the event was reported on a low frequency but randomly distributed among the manufactured batches that were distributed since the product's overseas launch in September 2011, Abbott Vascular requests that customers identify and return all HI family wires -TORQUE CONNECT GUIDE WIRE not used, regardless of batch number. #### Update (02/18/2014): According to a report sent by the company, 454 units of the product have already been collected until the date of 02/13/2014.
Cause
Possibility of partial lamination of the ptfe coating, with risk of embolism, thrombi and occlusion of the peripheral veins.
Action
Abbot Vascular is collecting the product from the market. Check your inventory and segregate the identified risk products. Contact the company for return purposes.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
BRAZIL-21.12.2001. The company reports that on September 18, 2001, Becton Dickinson & company; through its BD medical systens division, notified the FDA that it had identified through its own controls that batches 106170 and 108010 of the catheter insyte autoguard product, manufactured in its the sandy, utah-usa plant had micro-holes in the primary packaging. In order to prevent potential risks of adverse effects, the company voluntarily decided to collect these lots from the market. He also reports that no notification was sent to foreign governments by Becto Dickison's subsidiary due to the fact that the product was exclusively distributed on the American market.
Make sure that you have been contacted by BD Infusion Therapy Systems. Identify and isolate any affected product from your inventory. Contact BD Infusion Therapy Systems at the address listed to make arrangements for returning the product and obtaining the replacement product. For more information, contact your local BD representative or Rand Pugmire, recall coordinator, at (801) 565-2550 in the United States.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
An ecri member hospital reported that there was a failure of communication between the micro-electronic program components in the above radio-frequency generators. this communication failure puts the device in fail-safe mode, rendering it inoperative. the manufacturer states that this problem began on january 2, 2002. the manufacturer initiated a correction for a notification during the week of january 7, 2002 by federal express.
Action
Verify that you received the January 2002 Boston Scientific Correction Notice. Identify and isolate any affected product in your inventory. If your unit (s) has not received coverage from this service, please contact your EP Technologies sales representative, who will put you in touch with the appropriate person at Boston Scientific. For more information, contact Boston Scientific / EP Technologies in the USA by phone at (1408) 895-3626, or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
The above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
The above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
The above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
The above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
Water may evaporate from polyvinyl chloride bag on the heating gloves mentioned after long storage periods. this evaporation results in an increase in salt concentrations, which could increase the temperature of the sleeve and cause burns in the patient. aquarius medical has not received any complaint or report of injury caused by use of the above gloves mentioned. the manufacturer started a removal by correspondence dated 12 april 2000.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF 12 APRIL 2000 AND THE AQUARIUS MEDICAL PRODUCTION INFORMATION FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. DISCLAIMS THE USE AND DISTRIBUTION OF ANY DEFECTIVE PRODUCT, CONSIDER IT TO BE USED AND DESTRUCTES IT IN ACCORDANCE WITH APPLICABLE LAWS, REGULATIONS AND DECREES, FEDERAL, STATE AND LOCAL. PLEASE FILL OUT THE PRODUCTION INFORMATION FORM AND SEND TO AQUARIUS MEDICAL BY MAIL AT THE ABOVE ADDRESS OR BY FAX AT 1 (480) 991-4335. IF YOU PREFER TO RETURN THE DEFECTIVE PRODUCT, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH AQUARIUS MEDICAL BY PHONE 1 (480) 991-1818 TO RETURNED GOODS AUTHORIZATION NUMBER. FOR FURTHER INFORMATION, PLEASE CONTACT CHRISTINA FLEMING, AQUARIUS MEDICAL, BY PHONE1 (480) 991-1818, RAMAL 219.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
There is the possibility of corrosion of the mechanical relay that activates the energy fall alarm in the respirators mentioned. the manufacturer began a correction by correspondence sent on june 2, 2000.
Action
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT ON JUNE 2, 2000, BY BEAR MEDICAL SYSTEMS. IDENTIFY ANY AFFECTED PRODUCT IN YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE BEAR MEDICAL SYSTEMS DEPARTMENT OF TECHNICAL SERVICES BY PHONE 1 (760) 778-7300 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
There is the possibility of corrosion of the mechanical relay that activates the energy fall alarm in the respirators mentioned. the manufacturer began a correction by correspondence sent on june 2, 2000.
Action
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT ON JUNE 2, 2000, BY BEAR MEDICAL SYSTEMS. IDENTIFY ANY AFFECTED PRODUCT IN YOUR INVENTORY. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE BEAR MEDICAL SYSTEMS DEPARTMENT OF TECHNICAL SERVICES BY PHONE 1 (760) 778-7300 IN THE UNITED STATES
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
There is the possibility of corrosion of the mechanical relay that activates the energy fall alarm in the respirators mentioned. the manufacturer began a correction by correspondence sent on june 2, 2000.
Action
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT ON JUNE 2, 2000, BY BEAR MEDICAL SYSTEMS. IDENTIFY ANY AFFECTED PRODUCT IN YOUR INVENTORY. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE BEAR MEDICAL SYSTEMS DEPARTMENT OF TECHNICAL SERVICES BY PHONE 1 (760) 778-7300 IN THE UNITED STATES
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
There is the possibility of corrosion of the mechanical relay that activates the energy fall alarm in the respirators mentioned. the manufacturer began a correction by correspondence sent on june 2, 2000.
Action
MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT ON JUNE 2, 2000, BY BEAR MEDICAL SYSTEMS. IDENTIFY ANY AFFECTED PRODUCT IN YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE BEAR MEDICAL SYSTEMS DEPARTMENT OF TECHNICAL SERVICES BY PHONE 1 (760) 778-7300 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
01/30/2002 - The company informs that STENT VASCULAR PERIFERICO VASCUCOIL was not imported by Medtronic Comercial Ltda, or by any other authorized distributor, and consequently there is no unit of this product in Brazil.
Cause
The aforementioned sharp-tip reusable handles can be detached from the stent-graft catheter system. the distributor initiated a mailing removal dated june 13, 2000.
Action
Make sure that you have received the June 13, 2000 correspondence from Medtronic AVE. Identify and collect any affected product from your inventory. For product return information, please contact your Medtronic AVE representative or mail to the address listed above.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
An ecri member hospital reported that the defibrillation machines mentioned developed fissures and lasks through their borders as they were reterproofed in the time.
Action
ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) NOTIFY EMPLOYEES ABOUT THE PROBLEM, REMEMBER THAT THESE DEFIBRILLATION OPERATORS HAVE LIFE OF APPROXIMATELY 200 STERILIZATIONS AND ARE UNDER WARRANTY FOR 1 YEAR. IN ADDITION, ENSURE THAT THE DEFIBRILLATION ACTUATORS MADE BEFORE 1O. OF MARCH OF 1999 MAY BE MORE SUSCEPTIBLE TO FISSURES AND LASKS THAT MOST RECENT MODELS. (2) FOLLOW THE MANUFACTURER'S STERILIZATION GUIDELINES. (3) REPORT TO ANVISA AND THE MANUFACTURER IN CASE OF FISSURES AND LASKS APPEAR WITHIN THE WARRANTY PERIOD OF THE DEFIBRILLATION ACTUATOR SETS MADE AFTER 1O. OF MARCH 1999. (4) REPAIR ANY STERILIZABLE DEFIBRILLATION ACTUATOR SO THAT THEY REPEAT FISSURES OR LASKS AFTER REHOSTERILIZATION. (5) IF THE POSSIBILITY OF A PATIENT IS NECESSARY TO NEED DEFIBRILLATION DURING A PROCEDURE, CONSIDER PLACING DISPOSABLE ADHESIVES IN THE PATIENT BEFORE THE BEGINNING OF THE OPERATION BEFORE USING EXTERNAL DEFIBRILLATION PARTS. THIS WILL REDUCE THE NUMBER OF STERILIZATIONS OF THE DEFIBRILLATION ACTUATORS.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
The above mentioned nerve locator can operate intermittently, which may result in a lack of perception of stimulus when the nervous tissue is really touched by the stimulator. this false-negative response may be interpreted as the absence of nervous tissue. the manufacturer started a removal by correspondence dated of june 19, 2000.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE DATED CORRESPONDENCE OF JUNE 19, 2000 AND THE MEDTRONIC XOMED SURGICAL PRODUCTS CHECKLIST. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY USING THE CHECKLIST. RETURN THE PRODUCT AFFECTED FOR MEDTRONIC XOMED SURGICAL PRODUCTS AT THE ADDRESS REFERRED TO. MEDTRONIC XOMED SURGICAL PRODUCTS WILL ISSUE A CREDIT OR SEND A NERVE STIMULATOR / LOCATOR FOR ANY AFFECTED PRODUCT RETURNED. WHEN YOU SEND THE AFFECTED PRODUCT, CLEARLY IDENTIFY THE EXPORT PACKAGING PARTY ON THE OUTSIDE OF THE SHIPPING PACKAGE, THE PRODUCT RETURN AUTHORIZATION NUMBER SPECIFIED IN THE NOTIFICATION LETTER AND INCLUDE A COPY OF THE CORRESPONDENCE DATE OF JUNE 19, 2000 AND THE CHECKLIST FOR RECEIPT OF THE CREDIT. FILL IN THE CHECKLIST AND FAX FOR MEDTRONIC XOMED SURGICAL PRODUCTS 1 (904) 296-2386. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH MEDTRONIC XOMED SURGICAL PRODUCTS CONSUMER SERVICE BY PHONE 1 (904) 296-9600 IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
The aforementioned test discs have been labeled as a record of susceptibility tests on the cephalothionein, since the boxes contain titers of susceptibility to vancomycin. the distributor started a recall by dated correspondence of june 27, 2000. the company has provided no information to ecri.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF JUNE 27, 2000 FROM REMEL. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REMEL REPRESENTATIVE
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
The negative control dilute / sample of the kits of tests mentioned, indicate false-positive results. the manufacturer started a removal by correspondence, phone and fax on july 20, 2000.
Action
MAKE SURE THAT YOU HAVE BEEN RECEIVED AND RECEIVED THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS DECLARES THAT CONSUMERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO AFFIRMS THAT KIT DISTRIBUTORS SHOULD DISCONTINUE THEIR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS ON PHONE 1 (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT THE TECHNICAL SUPPORT DEPARTMENT OF YOUR LOCAL MERIDIAN DIAGNOSTICS REPRESENTATIVE
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
The negative control dilute / sample of the kits of tests mentioned, indicate false-positive results. the manufacturer started a removal by correspondence, phone and fax on july 20, 2000.
Action
MAKE SURE THAT YOU HAVE BEEN RECEIVED AND RECEIVED THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS DECLARES THAT CONSUMERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO AFFIRMS THAT KIT DISTRIBUTORS SHOULD DISCONTINUE THEIR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS ON PHONE 1 (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT THE TECHNICAL SUPPORT DEPARTMENT OF YOUR LOCAL MERIDIAN DIAGNOSTICS REPRESENTATIVE
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
Rings used in the diaphragm mechanism were inadvertely molded with the wrong nucleus pin, which could result in the leakage of the expiration valve if processed and remote. the manufacturer started a removal by correspondence dated 24 july 2000.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE DATED CHECK OF 24 JULY 2000 FROM INSTRUMENTATION INDUSTRIES. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR PRODUCT REPLACEMENT OR FOR FURTHER INFORMATION, CONTACT YOUR INSTRUMENTATION INDUSTRIES REPRESENTATIVE
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
In case of malfunctioning of the operational amplifier used in the skin temperature measurement circuit, the epithelial temperature probe of the above neonated incubators may super heat. draeger medical declares that excessive heating of the modeloo 8000 incubator probe results, as reported, in burns in a newborn in the united kingdom. draeger medical declares that the same electrical configuration is used in the modeloo rh600 radiant heater. the distributor started a correction by correspondence dated 2 july and 28 august 2000.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCES DATED 2 JULY AND 28 AUGUST 2000 AND THE DRAEGER MEDICAL RESPONSE CARD. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. DRAEGER MEDICAL RECOMMENDS TO TAKE THE FOLLOWING MEASURES: (1) DO NOT USE THE EPITHELIAL TEMPERATURE SENSORS CONNECTED DIRECTLY WITH THE DRAEGER MODELOO 8000 INCUBATOR OR WITH THE MODELOO RH600 RADIANT HEATER. (2) USE THIS EQUIPMENT ONLY IN ENVIRONMENTAL TEMPERATURE CONTROL MODE. (3) USE A SEPARATE TEMPERATURE MONITOR, IF NECESSARY. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO 8000 INCUBATOR UPGRADE OPTIONS: (1) REQUEST A DRAEGER MEDICAL UPDATE KIT. SEND THE FRAME OF FORMER PRINTED CIRCUITS (PCB) TO DRAEGER MEDICAL BY MAIL IN THE ADDRESS AFFECTED. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (2) IF THERE IS NO TIME AVAILABLE FOR EXCHANGE OF THE PCB, THE COMPLETE ELECTRONIC CONTROL MODULE CAN BE REMOVED AND SHIPPED TO DRAEGERSERVICE. DRAEGER MEDICAL DECLARES THAT IT WILL MAKE A COMPLETE PCB EXCHANGE AND A FREE PREVENTIVE MAINTENANCE. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (3) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT DOES NOT HAVE AN AUTHORIZED DRAEGER MEDICAL TECHNICIAN OR HAS NO TIME TO PERFORM OPTIONS 1 AND 2, DRAEGER MEDICAL DECLARES THAT A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SERVICE WILL MAKE THE UPDATE ON THE SITE. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO RH600 HEATER UPGRADE OPTIONS: (1) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT MAY PARTICIPATE IN THE UPDATE, DRAEGER MEDICAL AFFIRMS THAT THE HEATER MUST BE SUBMITTED FOR PROPER CHANGE. THE HEATER WILL BE RETURNED UPDATED AND WITH FREE PREVENTIVE MAINTENANCE WITHIN THE 2 DAYS USEFUL DEADLINE. THE BIOMEDICAL ENGINEERING PERSONNEL MAY THEN REINSTALL THE HEATER AND FILL IN THE FEEDBACK FORM. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. (2) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT CAN NOT PARTICIPATE IN THE UPDATE, SEND THE HEATER TO DRAEGER MEDICAL, WHICH WILL MAKE A COMPLETE UPDATE. A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SUPPORT SERVICE WILL VISIT YOUR HOSPITAL TO INSTALL THE UPDATED HEATER. PREVENTIVE MAINTENANCE WILL BE MADE FREE OF CHARGE. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. FILL IN AND SEND THE CONFIRMATION RESPONSE CARD TO THE MEDICAL DRAEGER BY MAIL AT THE ADDRESS AFFECTED. FOR FURTHER INFORMATION REGARDING CORRECTION CORRESPONDENCE, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH JAMES BRENNAN, DRAEGER MEDICAL, BY MAIL AT THE ADDRESS OR AT TELEPHONE 1 (215) 721-5400, RAMAL 2363, IN THE UNITED STATES. FOR FURTHER INFORMATION REGARDING THE USE OF THE AFFECTED PRODUCTS, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH HARALD KNEUER, DRAEGERSERVICE, TELEPHONE 1 (215) 721-5400 RAMAL 6917, IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
In case of malfunctioning of the operational amplifier used in the skin temperature measurement circuit, the epithelial temperature probe of the above neonated incubators may super heat. draeger medical declares that excessive heating of the modeloo 8000 incubator probe results, as reported, in burns in a newborn in the united kingdom. draeger medical declares that the same electrical configuration is used in the modeloo rh600 radiant heater. the distributor started a correction by correspondence dated 2 july and 28 august 2000.
Action
MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCES DATED 2 JULY AND 28 AUGUST 2000 AND THE DRAEGER MEDICAL RESPONSE CARD. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. DRAEGER MEDICAL RECOMMENDS TO TAKE THE FOLLOWING MEASURES: (1) DO NOT USE THE EPITHELIAL TEMPERATURE SENSORS CONNECTED DIRECTLY WITH THE DRAEGER MODELOO 8000 INCUBATOR OR WITH THE MODELOO RH600 RADIANT HEATER. (2) USE THIS EQUIPMENT ONLY IN ENVIRONMENTAL TEMPERATURE CONTROL MODE. (3) USE A SEPARATE TEMPERATURE MONITOR, IF NECESSARY. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO 8000 INCUBATOR UPGRADE OPTIONS: (1) REQUEST A DRAEGER MEDICAL UPDATE KIT. SEND THE FRAME OF FORMER PRINTED CIRCUITS (PCB) TO DRAEGER MEDICAL BY MAIL IN THE ADDRESS AFFECTED. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (2) IF THERE IS NO TIME AVAILABLE FOR EXCHANGE OF THE PCB, THE COMPLETE ELECTRONIC CONTROL MODULE CAN BE REMOVED AND SHIPPED TO DRAEGERSERVICE. DRAEGER MEDICAL DECLARES THAT IT WILL MAKE A COMPLETE PCB EXCHANGE AND A FREE PREVENTIVE MAINTENANCE. DRAEGER MEDICAL DECLARES THAT ALL REPLACEMENTS OF PARTS AND DELIVERY WILL BE MADE FREE OF CHARGE. (3) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT DOES NOT HAVE AN AUTHORIZED DRAEGER MEDICAL TECHNICIAN OR HAS NO TIME TO PERFORM OPTIONS 1 AND 2, DRAEGER MEDICAL DECLARES THAT A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SERVICE WILL MAKE THE UPDATE ON THE SITE. DRAEGER MEDICAL OFFERS THE FOLLOWING MODELOO RH600 HEATER UPGRADE OPTIONS: (1) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT MAY PARTICIPATE IN THE UPDATE, DRAEGER MEDICAL AFFIRMS THAT THE HEATER MUST BE SUBMITTED FOR PROPER CHANGE. THE HEATER WILL BE RETURNED UPDATED AND WITH FREE PREVENTIVE MAINTENANCE WITHIN THE 2 DAYS USEFUL DEADLINE. THE BIOMEDICAL ENGINEERING PERSONNEL MAY THEN REINSTALL THE HEATER AND FILL IN THE FEEDBACK FORM. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. (2) IF YOUR BIOMEDICAL ENGINEERING DEPARTMENT CAN NOT PARTICIPATE IN THE UPDATE, SEND THE HEATER TO DRAEGER MEDICAL, WHICH WILL MAKE A COMPLETE UPDATE. A REPRESENTATIVE OF THE DRAEGER MEDICAL TECHNICAL SUPPORT SERVICE WILL VISIT YOUR HOSPITAL TO INSTALL THE UPDATED HEATER. PREVENTIVE MAINTENANCE WILL BE MADE FREE OF CHARGE. ALL PARTS AND DELIVERY WILL BE MADE FOR FREE. FILL IN AND SEND THE CONFIRMATION RESPONSE CARD TO THE MEDICAL DRAEGER BY MAIL AT THE ADDRESS AFFECTED. FOR FURTHER INFORMATION REGARDING CORRECTION CORRESPONDENCE, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH JAMES BRENNAN, DRAEGER MEDICAL, BY MAIL AT THE ADDRESS OR AT TELEPHONE 1 (215) 721-5400, RAMAL 2363, IN THE UNITED STATES. FOR FURTHER INFORMATION REGARDING THE USE OF THE AFFECTED PRODUCTS, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH HARALD KNEUER, DRAEGERSERVICE, TELEPHONE 1 (215) 721-5400 RAMAL 6917, IN THE UNITED STATES.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
An ecri member hospital reported an incident in which a physiological monitor interfered on the wav potential evocado of an evolved electromiography / potential equipment (emg / ep).
Action
TO REDUCE THE EMISSION OF ELECTROMAGNETIC INTERFERENCE, EMI, AND MINIMIZE THE EFFECTS OF EMISSIONS IN HOSPITAL EQUIPMENT, ECRI RECOMMENDS THAT THE FOLLOWING: (1) MAKE SURE THAT APPROPRIATE FILTER ASSEMBLIES ARE SELECTED FOR SENSITIVE RECORDING EQUIPMENT. (2) REMOVE SENSITIVE EQUIPMENT FROM THE NEARBY OF OTHER ELECTRONIC EQUIPMENT, WHEREVER IT IS POSSIBLE. (3) USE DIFFERENT EQUIPMENT, IF NECESSARY. ECRI RECOMMENDS THE ADOPTION OF THE FOLLOWING PROCEDURES IN EQUIPMENT WITH ELECTRODES, CONDUCTOR WIREs AND CABLES FOR MINIMIZING EMI EMISSIONS: (1) ENSURE THAT GOOD QUALITY ELECTRODES ARE USED AND THAT ARE PROPERLY POSTED TO THE PATIENT. (2) IF STIMULATION AND RECORDING ELECTRODES ARE USED SIMULTANEOUSLY, SEPARATE THE TWO TYPES OF ELECTRODES TO THE MAXIMUM POSSIBLE. (3) KEEP THE DRIVING WIRES ORIGINATED FROM A SINGLE SOURCE, WHETHER AN INDIVIDUAL EQUIPMENT, AS AN EMG, OR A COMPOUND, AS THE MONITORING MODULE, GROUPED TO THE LARGE EXTENT POSSIBLE TO MINIMIZE MAGNETIC AND ELECTRICAL DISTURBANCES. (4) WHEN POSSIBLE, DIRECT THE ORIGINATED WIRES OF DIFFERENT SOURCES FOR DIFFERENT DIRECTIONS AND AVOID THE WIRING OF WIRES OF DIFFERENT EQUIPMENT. TO REDUCE EMI EMISSIONS FROM THE ENERGY SOURCE OF THE EQUIPMENT, ECRI RECOMMENDS TO TAKE THE FOLLOWING PRECAUTIONS: (1) CONNECT MEDICAL EQUIPMENT TO TAKEN WITH PROPER LANDING; TEST DIFFERENT TAKES AND OBSERVE THE EFFECTS ON THE OPERATION OF THE EQUIPMENT. (2) IMPLEMENT AN ENERGY QUALITY PROGRAM IN PARTNERSHIP WITH THE ELECTRICITY COMPANIES, HOSPITAL OFFICIALS AND FINAL USERS TO MINIMIZE THE INTERFERENCE OF DRIVING CABLES AND ENERGY FREQUENCY. ECRI RECOMMENDS THAT YOU ALWAYS CONSIDER EMI AS A POTENTIAL SOURCE OF THE MALFUNCTIONING OF EQUIPMENT, ESPECIALLY WHEN THE READING OF THE EQUIPMENT SEEMS TO BE AFFECTED BY NOISE, SORRY OF THE EQUIPMENT BE DULY CONNECTED AND POSTED TO THE PATIENT. IF ANY EMI PROBLEMS ARE SUSPECTED, CHECK THE DOCUMENTATION OF ANY ELECTRONIC HOSPITAL EQUIPMENT THAT IS BEING USED IN THE AREA. WHEN YOU ARE VERIFYING THE DOCUMENTATION, ECRI RECOMMENDS YOU TO VERIFY: (1) IF THE EQUIPMENT IS CLASS A OR B, BECAUSE THE CLASS EQUIPMENT IS EMITTED TO GREATER ELECTROMAGNETIC ENERGY, AND (2) EMI'S SPECIFIC RECOMMENDATIONS FROM THE MANUFACTURER. ECRI RECOMMENDS THAT USERS AND CLINICAL ENGINEER EMPLOYEES SHOULD ALWAYS BE ALTHOUGH YOU HAVE EMI PROBLEMS. IN ADDITION, ECRI RECOMMENDS THAT EMPLOYEES SHALL BE INFORMED OF THE EFFECTS EMI MAY HAVE IN THE OPERATION OF EQUIPMENT AND RECOMMENDATIONS BY ECRI FOR THE REDUCTION OR DISPOSAL OF INTERFERENCE. FOR FURTHER INFORMATION REGARDING ECRI'S EMI RISK REPORT, CONTACT CARLOS FORNAZIER, AT THE ELECTRONIC MAIL TECNOVIGILANCIA@ANVISA.GOV.BR OR BY PHONE 0XX-61-4481331.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
An ecri member hospital reports that when using the model 0606-0300-50 laserscope pulsar / carbon dioxide (co2) lasers for throat surgery, the otolaryngologist complained that the helio / neon laser beam (hene) , which indicates the area where the laser will reach the tissue, was not clear enough to be used.
Action
ECRI makes the following recommendations: (1) Examine the target beam conditions of any Pulsar / Paragon CO2 laser in your hospital during inspection and preventive maintenance to detect any wear of the attenuator over time. Make sure that the aiming beam is immediately visible, especially when used with external light sources. (2) If the beam does not appear to be clear enough, make sure it is set to maximum intensity. If this does not solve, exclude other problems, such as those involving the micro manipulator or wear of the HeNe tube or the power source. (3) If the attenuator is the problem, consider removing the HeNe attenuator assembly (or ask the Laserscope manufacturer to do so). By doing so, you will be avoiding the effort and expense of having to incorporate a Laserscope crosshair upgrade kit, however this will also eliminate the ability to adjust the beam brightness (4) If this does not work , install the Laserscope NeHe upgrade kit. Contact your local representative or directly with Laserscope at 1 (408) 943-0636 in the United States to discuss this option. It may be covered by the original service agreement (warranty) or warranty. Otherwise, Laserscope has stated that the total cost of the service is $ 3,900 (including labor and travel). For more information, contact your local representative or directly with Laserscope at 1 (408) 943-0636 in the United States at fax 1 (408) 428-0512, or visit the Laserscope Web site at http: / /www.laserscope.com
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
Cause
The united kingdom medical equipment agency (mda) issued a security notification notice that the adapters mentioned can present a crack beginning at the alignment cab or at the back of the screw. this cracking can progress up to the total breakage could cause injury to users.
Action
MDA RECOMMENDS THAT HEALTH CARE PROVIDERS DO THE FOLLOWING: (1) NOTIFY EMPLOYEES RESPONSIBLE FOR PROVIDING, ASSEMBLING AND MAINTAINING EXTERNAL PROSTHESES OF LOWER MEMBERS USING THE AFFECTED ADAPTERS. (2) CALL THE USERS FOR REVISION OF THE ORTHOS AND REPLACE ALL EXTERNAL PROSTHESES OF THE LOWER MEMBERS USING THIS PRODUCT AFFECTED OF THE LOTS WITH THE NUMBERS MENTIONED. (3) READ THE TECHNICAL MANUAL TO ENSURE THAT THE ADAPTERS OF THE AFFECTED SOCKETS ARE PROPERLY PLACED, SINCE SOME UNITS WERE INCORRECTLY MOUNTED. REVISED ADAPTERS BRING A PRINTED TEXT IN THEM TO GUARANTEE CORRECT RADIAL LOCATION.