Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
It has been brought to the attention of welch allyn via customer complaints in the uk that under certain circumstances the power supply casing at the weld joint (housing) can separate which, as a result, exposes electrical components.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
In the course of our post market surveillance activities we observed that the ultrasound probe cover kit with gel was found the burkholderia multivorans, bukholderia cenocepacia, bacillus beringensis, bacillus circulans inside, which pointed that the gel was the source of pollution.
Greek data is current through July 2018. All of the data comes from the National Organization for Medicines, 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 recall data from the U.S. and Greece.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Yuyao yufeng medical equipment co., ltd is issuing a field safety notice to advise
users of an update to the instructions for use (ifu) for oxygen regulator yf-86-a
per the enclosed attachment (attachment 1). this information will be included in the
ifu & cartons of all future units distributed by yufeng medical.
this ifu update provides clear information about cleaning & disinfection method for
oxygen regulator yf-86-a.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Zethon has identified that there is no documented evidence that they meet the basic safety and performance requirements of the medical device regulations. this effectively invalidates the ce-mark (found on the label and insert), and zethon is recalling the product with immediate effect.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Cause
Ziehm imaging has been notified by its supplier that some type kf21 double foot switches may fail to switch off radiation after starting the exposure.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: BfArM
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Zimmer biomet states that the nut that interfaces with the outer plate of the above clamps may be misassembled, potentially leading to a delay in surgery or intervention necessitated by postoperative device failure.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Internal investigation found that the screwdriver blade (2.3 mm) was mislabeled. following inspection of the product, it was determined that they were erroneously marked as screwdriver blade cross-lock mid 1.7, dental-end;
lot (16688), item (503004417).
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The issue concerns a mix up of two lots of ncb screws with different lengths but the same diameter (4mm). ncb screws with a length of 26mm were placed in the 32 mm packaging and vice versa. these trauma screws are delivered non sterile and are placed in the implant rack and sterilized before use. as a general practice, screw length is checked before placing the screw into the right place of the implant rack (figure 1). this is done using a template which is incorporated into the rack itself. during the surgery, when picking a screw, the nurse checks the length of screw once again using the same template.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Zimmer biomet is initiating a lot specific recall of the nexgen precoat tibial plate and nexgen option tibial plate due to a
commingle between the affected lots of the same size tibial components. a field complaint was received indicating the nexgen
option tibial plate from lot 62460315 was found in the package for a nexgen precoat tibial plate from lot 62491580.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
This recall is initiated due to lack of a steam sterilization validation to support the sterilization parameters stated in the instructions for use (ifu) (030ean0000t and 030ean0000i).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The packages contained the wrong patient label. where the wrong patient label is being used for documentation of the implanted device, the wrong lot and size will be recorded in the patient record. with later inquiries, this could potentially lead to an incorrectly prepared revision surgery (wrong size insert selected).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Zimmer has determined that the femoral component of a knee implant has an undersized cam radius due to a manufacturing error. this may cause polyethylene delamination and fatigue fracture due to higher contact stresses. zimmer is not recommending any enhanced patient follow-up.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
In rare cases, product information on the patient label, with respect to ref number! lot number might not
coincide with the corresponding information on the product label.
while the information printed on the product label is always correct. the information on the patient label (in rare
cases) may be wrong.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The manufacturer has determined that the current information as described in the instructions for use (ifu) and in the product brochure was confusing.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Zimmer biomet is conducting a medical device market removal for the echo instrument case shell tall outer case vault only and the comprehensive primary shoulder instrument outer case vault only as they do not comply with the weight recommendation in the current ansi/aami st79 and iso 17665-2006 standards.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The spring and washer to keep the pole plug in place are missing on the devices.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The tip of the rod holder may crack or break when the rod is manipulated during surgery.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notes supplémentaires dans les données
Cause
The cause of the sanitary wing is due to a valve failure that prevents the balloon from inflating and deflating properly. if a patient requires circulatory support with an iabp (balloon intra-aortic pump) and the device does not work, or if the treatment is stopped during use without a replacement iabp available, device failure may result in immediate adverse consequences and serious for health, including death. the sanitary registry im011319012017 covers the model cs300 visits the distributor's facilities and requested documentation of imports and stocks, where it was stated that no related imports had been made since 2012 and that the company's knowledge said affected equipment are outside of uses since they were replaced by more recent technology in 2016.
Action
Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment.
- Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Zimmer is initiating a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. specifically, multiple test samples from each of the two configurations failed simulated distribution and shipping testing. the devices impacted are generally the heaviest outlier sizes within the respective product family. below are photos representative of failures seen during this testing.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notes supplémentaires dans les données
Cause
- the products have been classified as forged.
- the owner of the product mentions that hypak pre-filled syringes are no longer manufactured.
- it is reported that the dnm will continue surveillance actions, such as the insurance of products, to avoid the sale of them because they represent a risk to the population.
- include within the list of falfra.
Action
1. Notice to the population not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any pharmaceutical establishment.
2. Perform searches of the product in the BPAs or routine searches.
3. Communication of the international alert.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notes supplémentaires dans les données
Cause
- the aforementioned product was investigated, confirming that it does not correspond to the one legitimately manufactured by gsk, presenting difference in the placement of the texts, difference in the barcode, difference in the device, difference in the insert, difference in the watermark in the safety labeling and in the inhaler bottle, the expiration date which does not correspond to the life time of the product. the product can be recognized by consigning the lot number a22m and expiration date june 2019.
- the conditions of manufacture and packaging, the qualitative formula, the quality of the raw materials used and the finished product are unknown.
- include within the list of falfra.
Action
- Notice to the population not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensing of this product within any pharmaceutical establishment.
- Perform searches of the product in the BAPs or routine searches.
- To find the product in existence within the country, a national alert will be issued.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notes supplémentaires dans les données
Cause
Possible false negative or false positive results for hiv infection obtained with the use of the test. because it is possible that the treatment of a patient who is hiv positive is delayed and a subsequent transmission of the infection is reproduced, so there is no certainty of its safety, quality and efficacy.
Action
1. Withdrawal of medication from the national market.
2. Notice to the population of the non-consumption of the drug product.
3. Verification of the Destruction of the non-compliant medication.
4. Communication of the international alert.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
Notes supplémentaires dans les données
Cause
The cause of the sanitary alert is due to the possible delivery of insulin, which can cause hypoglycaemia and, in extreme cases, death. the sanitary register im101306072017 covers the minimed model. the distributor's facilities were visited and documentation of imports and inventories was requested, the distributor provided a list of lots that are within the alert, as well as instructions from the manufacturer on how to address said alert. so we proceeded to verify and seal the units identified in the alert that were in the warehouse, also, the company said that they had already notified customers to change the product.
Action
- Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment.
- Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices