FDAFDA · Food and drugs·Recall number Z-3148-2024
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Published September 25, 2024 · Recall initiated: July 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- US, Colombia, Philippines, Russia
- Lot
- GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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