Reported Sep 25, 2024 · Ongoing
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Flexima APDL Drainage Catheter System and Kit
- Material Numbersa) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
- Lot codes and dates
a) GTIN/UDI 0871472932347Lot # 33540319Exp. 03/01/2027b) GTIN/UDI 0871472932348Lot # 33471466Exp. 02/21/2027
- Amount recalled
- 89 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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