U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Mako has identified the potential that the shell impactors may be damaged intraoperatively.
Action
MAKO Surgical Corporation sent an Important Medical Device Recall Notice dated October 7, 2014, to all affected customers. The letter identified the product, the problem, and hte action to be taken by the customer. Customers were instructed to review their inventory for the affected product and return affected inventory to MAKO, Ft. Lauderdale. Customers were instructed to provide the Recall Notification to all field personnel to enhance awareness of the event. Customers were instructed to complete the attached acknowledgement form indicating receipt of the notice. Customers were asked to sign and return the form to MAKO Surgical by the following methods:
Email: SYKMakoFLQualitySystems@stryker.com
Fax to (954) 423-1547
Mail using enclosed self addressed stamped envelope tp:
MAKO Surgical Corporation
2555 Davie Road
Ft. Lauderdale, FL 33317
so that the field personnel
1) Recall Notification communicated by MAKO Customer Service on 10/7/2014 to affected MAKO field personnel, directing them to review their affected customer's site inventory and return affected inventory to MAKO Ft. Lauderdale. Field personnel will sign an Acknowledgment form and return it to MAKO Quality.
2) Recall Notification communicated by MAKO Quality department to the affected sites OR Administrators notifying them of the recall event and providing an Acknowledgment form for return to MAKO Quality to document their awareness.
3) The Recall Notification provided to all MAKO field personnel to enhance awareness of the event so that the field personnel can provide answers to questions their site personnel may have regarding the event.
If you have any questions contact us at (954) 628-1721.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Mako has identified the potential that the shell impactors may be damaged intraoperatively.
Action
MAKO Surgical Corporation sent an Important Medical Device Recall Notice dated October 7, 2014, to all affected customers. The letter identified the product, the problem, and hte action to be taken by the customer. Customers were instructed to review their inventory for the affected product and return affected inventory to MAKO, Ft. Lauderdale. Customers were instructed to provide the Recall Notification to all field personnel to enhance awareness of the event. Customers were instructed to complete the attached acknowledgement form indicating receipt of the notice. Customers were asked to sign and return the form to MAKO Surgical by the following methods:
Email: SYKMakoFLQualitySystems@stryker.com
Fax to (954) 423-1547
Mail using enclosed self addressed stamped envelope tp:
MAKO Surgical Corporation
2555 Davie Road
Ft. Lauderdale, FL 33317
so that the field personnel
1) Recall Notification communicated by MAKO Customer Service on 10/7/2014 to affected MAKO field personnel, directing them to review their affected customer's site inventory and return affected inventory to MAKO Ft. Lauderdale. Field personnel will sign an Acknowledgment form and return it to MAKO Quality.
2) Recall Notification communicated by MAKO Quality department to the affected sites OR Administrators notifying them of the recall event and providing an Acknowledgment form for return to MAKO Quality to document their awareness.
3) The Recall Notification provided to all MAKO field personnel to enhance awareness of the event so that the field personnel can provide answers to questions their site personnel may have regarding the event.
If you have any questions contact us at (954) 628-1721.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Mesh, surgical, polymeric - Product Code FTL
Cause
The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the bard small perfix light plug.
Action
Davol Inc. (Subsidiary of C.R. Bard, Inc)sent Customer Notification letters on Friday, October 10, 2014, via FedEx next day delivery with signature confirmation to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Action required:
Examine your inventory and identify any product subject to this communication. A sample of the product labeling for the lot has been enclosed to assist in product code and lot number identification. The enclosure also depicts the supplied label as well as an image of the label with the correct information.
If you have any remaining inventory, a copy of this communication can be kept with the units for future medical record documentation purposes.
If you have already used some of the product lot, you may amend any patient record(s) based upon the content of this communication.
Please complete and return the accompanying Effectiveness Check Form attached to this letter regardless of whether or not you have any remaining units of the affected product lot.
If you may have further distributed or transferred this product, please identify the respective organizations and notify them of this product communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter.
This product communication is being made with the knowledge of the Food and Drug Administration. We apologize for any inconvenience this may have caused your organization. Please contact the Davol Customer Service Department at 1-800-556-6275 or C.R. Bard Medical Services & Support Department at 1-800-562-0027 if you have any questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Mako has identified the potential that the shell impactors may be damaged intraoperatively.
Action
MAKO Surgical Corporation sent an Important Medical Device Recall Notice dated October 7, 2014, to all affected customers. The letter identified the product, the problem, and hte action to be taken by the customer. Customers were instructed to review their inventory for the affected product and return affected inventory to MAKO, Ft. Lauderdale. Customers were instructed to provide the Recall Notification to all field personnel to enhance awareness of the event. Customers were instructed to complete the attached acknowledgement form indicating receipt of the notice. Customers were asked to sign and return the form to MAKO Surgical by the following methods:
Email: SYKMakoFLQualitySystems@stryker.com
Fax to (954) 423-1547
Mail using enclosed self addressed stamped envelope tp:
MAKO Surgical Corporation
2555 Davie Road
Ft. Lauderdale, FL 33317
so that the field personnel
1) Recall Notification communicated by MAKO Customer Service on 10/7/2014 to affected MAKO field personnel, directing them to review their affected customer's site inventory and return affected inventory to MAKO Ft. Lauderdale. Field personnel will sign an Acknowledgment form and return it to MAKO Quality.
2) Recall Notification communicated by MAKO Quality department to the affected sites OR Administrators notifying them of the recall event and providing an Acknowledgment form for return to MAKO Quality to document their awareness.
3) The Recall Notification provided to all MAKO field personnel to enhance awareness of the event so that the field personnel can provide answers to questions their site personnel may have regarding the event.
If you have any questions contact us at (954) 628-1721.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Introducer, Catheter - Product Code DYB
Cause
Sheaths may fracture if exposed to excess fluorescent light.
Action
The recalling firm issued a letter to the distributor on 10/15/04 via fax and Federal Express. The letter informed them of the product and the need to return the product. The account was instructed to conduct a sub-recall.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm, Exactech, sent an "Urgent Field Safety Notice" letter dated September 30, 2014 to its Consignees/customers by electronic mail on October 9, 2014. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately cease distribution or use of the products; extend information to your accounts that may have this product in their possession; verify whether you have any of the subject femoral components from the specified serial number ranges; complete and return the attached inventory RESPONSE FORM via fax to: 011 61 2 9638 0778 within 48 hrs of receipt of the notice, and contact your Exactech representative to confirm quantities at your location and arrangements for product return and inventory restocking.
If you have any questions, contact Manager, Regulatory Affairs at 352-377-1140.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Martara instrument, inc. has recently became aware of a potential safety hazard involving our surveyor rand s12 s19 patient monitors. a hazardous situation may be created when mounting these monitors using the 75mm vesa mounting hole pattern provided in the battery cover of these monitors. if the mounting screws provided by mortara are not used and if the mounting screws used are longer than the p.
Action
Mortar Instruments, Inc. sent an "Urgent Medical Device Correction" letter dated October 3, 2014. The letter was addressed to Health Care Administrator / Risk Manger and Director of Biomedical / Clinical Engineering.The letter described the problem and the product involved in the recall. Customers were advised to contact Mortara Technical Support at 1-888-667-8272 or TechSupport @mortara.com to schedule a service representative to update their Surveyor S12 and Surveyor S19 units or for additional questions they can contact their local Service Representative. The update will include replacement of the battery cover and replacement of the battery pack if mounting screw damage is evident.
International consignees received similar dated letter except it provided instructions detailing the correction steps and requested customers to complete and return the Response Acknowledgement and Receipt Form. For questions they can contact Technical Support at +1.414.354.1600 or TechSupport@mortara.com, or contact your local Service Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There are additional and updated warning and cautions that are not in the patient at-home guide for homechoice automated pd systems and homechoice pro automated pd systems.
Action
The firm, Baxter, sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 6, 2014 to all peritoneal dialysis provider direct accounts. Baxter also sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 9, 2014 to all peritoneal dialysis patient direct accounts The letters described the product, problem and actions to be taken. The letters included instructions for the recipients to complete the attached Customer Reply Form and to return it to Baxter via scanned e-mail to: fca@baxter.com or fax : 224-270-5457. In addition, the letter to patients instructed them to contact their healthcare provider to discuss this issue.
Customers with clinical questions should contact Baxter's Renal Division Clinic Helpline at 888-736-2573, option 2 (8:00 AM - 5:00 PM CST).
Adverse reaction or quality problems experienced with the use of these product can be reported by contacting Baxter Product Surveillance at 800-437-5176 (Monday - Friday, 8:00 AM - 5:30 PM CST) or e-mail to corporate_product_complaints_round_lake@baxter.com.
Customers with general questions about the letter should contact The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The 5085 and 5085srt stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. severe damage to the shrouds may prevent the user from raising or lowering the surgical table.
Action
STERIS will mail Consignee Notification Letters to the affected Consignees via FedEx with tracking numbers for delivery confirmation. The Consignee Notification mailing will initiate the week of October 13, 2014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Wheelchair, mechanical - Product Code IOR
Cause
Silver star brands is recalling the transport chair and rollator in one because they have received several reports of the wheel assembly failing resulting in damaged wheels.
Action
Consignees were sent on 10/10/2014 an Easy Comforts "Urgent: Rollator Recall" letter dated October 10, 2014. The letter described the problem and the product involved in the recall. Advised consignees to stop using the product immediately. The consignees can contact the Product specialist at Easy Comforts at 1-888-327-2390 Monday though Friday from 7:30 am to 3:30 pm central time.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Interventional fluoroscopic x-ray system - Product Code OWB
Cause
Ge healthcare initiated a field correction because prior revision of components were potentially installed on certain oec 9800, flexiview 8800, oec miniview 6800 and oec uroview 2800 systems.
Action
On October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to
customers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter
was sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and
Radiologists, 3.) Radiology Department. Firm will track all
service requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Cause
Ge healthcare initiated a field correction because prior revision of components were potentially installed on certain oec 9800, flexiview 8800, oec miniview 6800 and oec uroview 2800 systems.
Action
On October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to
customers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter
was sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and
Radiologists, 3.) Radiology Department. Firm will track all
service requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Cause
Ge healthcare initiated a field correction because prior revision of components were potentially installed on certain oec 9800, flexiview 8800, oec miniview 6800 and oec uroview 2800 systems.
Action
On October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to
customers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter
was sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and
Radiologists, 3.) Radiology Department. Firm will track all
service requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Interventional fluoroscopic x-ray system - Product Code OWB
Cause
Ge healthcare initiated a field correction because prior revision of components were potentially installed on certain oec 9800, flexiview 8800, oec miniview 6800 and oec uroview 2800 systems.
Action
On October 3. 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to
customers to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter
was sent to 3 titles at each facility affected: 1.1 Facility Administrator. 2.1 Director/Manager of Radiology and
Radiologists, 3.) Radiology Department. Firm will track all
service requests for the field action to completion. These service requests will document the inspection and component replacement (if applicable) on the affected units. Exceptions to completion of the service request will be recorded. Records of field action completion will be retained per our processes and procedures. No product is being returned.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, angiographic - Product Code IZI
Cause
The small focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. the large focus and micro focus focal spots will still be operational without any restriction. manual switchover is needed, resulting in a short interruption of the procedure.
Action
Planned action (s) to repair defect or to bring product into compliance for Siemens Medical Solutions Inc. concerning the corrective action plan (CAP) for the Model(s) Artis Zee/Zeego Stationary Angiographic X-ray Systems.
1.Notifying the customer of the defect.
2.Implementing a corrective software patch to protect the system from damage in
the event of hardware failure
3. Scheduling a service visit from a Siemens representative to perform a hardware replacement.
4. Replacing the non-conforming X-ray tube with one manufactured after the nonconformity issue was resolved.
For further questions please call (610) 219-6300.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Catheter, percutaneous - Product Code DQY
Cause
Two reports have been received on the 6f launcher guide catheter lot (model number la6jr40k; lot no 0007244836} for incorrect usable length of the guide catheter. it was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the.
Action
Beginning October 13, 2014, Medtronic field representatives will being hand delivery of the customer communication to affected customers, notifying them of the issue, and requesting return of unaffected product. Customers will be asked to sign a certificate confirming they have received the notification and have taken the requested action.
1. Identify and quarantine all listed, unused product in your inventory.
2. Return all listed product in your inventory to Medtronic. Contact Customer Service at 888-283-7868 to initiate a product return and credit. Your Medtronic sales representative can assist you in the return of this product as necessary.
3. Complete the attached Customer Confirmation Certificate and email it to RS.CFQFCA@Medtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Rod, fixation, intramedullary and accessories - Product Code HSB
Cause
Medacta has registered in its database 3 cases of breakage of the gmk intramedullary extension
rod 100 mm, code 02.07.10.0162.
Action
Medacta sent an URGENT MEDICAL DEVICE letter dated September 22, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its inventory of the device; 2) quarantine and do not use the recalled device; and, 3) return the recalled device upon receipt of a RMA # from the Medacta QA Department. For questions regarding this recall call 805-910-6511.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Portions of the lots may contain units with an incorrect lens axis condition.
Action
This recall is being initiated to the wholesale/distributor and Eye Care Practitioner
level.
Written communications will be forwarded to all first level consignees by overnight
mailin..9. Receipt" tracking and follow up with consignees will be conducted according to
the Effectiveness Check noted below. . - .
The 0ff Axis condition is ~onsistent with a situation in which use of, or exposure to, the
product is unlikely to cause adverse health consequences. A user may notice blurred
vision due¿ to the axis being out of specification but removal of the lens effectively
reduces/eliminates any impairment. There is currently no indication that use of a lens
with an Off Axis condition will create an injury requiring medical intervention. No
permanent impairment is anticipated with or without medical intervention.
Based on the analysis " described in the attached Health Hazard Evaluation,
CooperVision will initiate a Class Ill recall. As noted by regulation, this classification is
consistent with a situation in which use of, or exposure to, the product is unlikely .to
cause adverse health consequences. Our evaluation of the Off Axis condition indicates
it is unlikely to cause an adverse health reaction.
Based on a Class Ill determination, the recall shall be conducted to the Wholesale
level with a planned Effectiveness Check at Level B - 50% of Consignees to be
contacted.
Public Warning- in light of the low risk and proposed recall classification; a public
warning is not warranted at this time.
Distribution includes:
" North America: Canada, USA
" Latin America: Argentina, Brasil, Chile, Colombia, Ecuador, Guatemala, Uruguay,
Venezuela, Mexico
" Europe: Belgium, Denmark, Germany, France, Netherlands, Poland, Spain, Sweden,
Switzerland
" Australia
Returned lenses will be quarantined from distribution and destroyed as required.
Actions and Dates:
" Notify FDA through 806 Form on 10/23/14
" Initiate External communications starting 10/28/2014
" C
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Introducer, catheter - Product Code DYB
Cause
St. jude medical is conducting a voluntary recall of smj batch # 4641580 of the fast-cath trio" hemostasis introducer, catalog number 406308. the inner diameter of the 10f dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.
Action
St. Jude Medical sent an Urgent Medical Device Recall Notice dated October 14, 2014, to all affected consignees. The letter described the problem and the product affected by the recall. Advised consignees to discontinue us of the device. A St. Jude Medical sales representative were to contact the consignee in the near future to facilitate removal and reconciliation of the recalled device. Customers with questions were instructed to contact their St. Jude Medical sales Representative.
For questions regarding this recall call 651-756-2295.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
St. jude medical is performing a voluntary recall of batch 4671318, model number 401353 of the response fixed curve deca 6f 65cm csl 2/8 catheter. specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (supreme fc quad 5f catheter) within the packaging. to date, no serious injuries have occurred as a result of this issue.
Action
St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Manual antimicrobial susceptibility test systems - Product Code JWY
Cause
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
Action
Consignees of bioM¿rieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on October 16th, 2014. Additionally, the bioM¿rieux United States subsidiary notified US consignees of the FSCA notification via FedEx on October 23rd, 2014.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Monteris medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Action
Monteris Medical sent an Urgent Advisory Notice of Product Recall letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Action to be taken by user:
Our distribution records document that you were shipped products from the affected lots. Please check your inventory to confirm whether you have any stock affected by this notice. An acknowledgment form is included to assist you in the assessment of your inventory. Your Monteris Medical Sales Representative will be glad to assist you with this assessment.
Once your inventory has been verified, please fax the form back to Monteris Medical at 763-253-4728.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Monteris medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Action
Monteris Medical sent an Urgent Advisory Notice of Product Recall letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Action to be taken by user:
Our distribution records document that you were shipped products from the affected lots. Please check your inventory to confirm whether you have any stock affected by this notice. An acknowledgment form is included to assist you in the assessment of your inventory. Your Monteris Medical Sales Representative will be glad to assist you with this assessment.
Once your inventory has been verified, please fax the form back to Monteris Medical at 763-253-4728.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Supplement, culture media - Product Code JSK
Cause
Recalled product may not provide adequate recovery of legionella pneumophila when used as directed and may result in false negative identification of legionella pneumophila.
Action
Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The recall was initiated because biosense webster is providing additional labeling for the safe and effective use of the thermocool smarttouch catheter.
Action
A customer notification letter dated October 19, 2014, will be sent to all customers who purchased the Biosense Webster's ThermoCool SmartTouch Catheter Family. The letter informs the customers of the additional information for the safe and effective use of the ThermoCool SmartTouch Catheter, which will be included in the updated labeling. The letter informs the customers of the problems identified and the actions to be taken.
Customers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7am to 8pm EST.