Boston Scientific Corporation 2024-09-25 Health serious FDA
Health · FDA · Recall #FDA-Z-3149-2024
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To… Recall
Issued September 25, 2024 · Boston Scientific Corporation
In September 2024, Boston Scientific Corporation recalled the Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
What you should do
- 1 Stop using Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Boston Scientific Corporation
- Category
- Health
- Recall date
- September 25, 2024
- Units affected
- Not reported
- Sold at
- US, Colombia, Philippines, Russia
- Recall number
- FDA-Z-3149-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.