Z-3148-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2024
- Initiation Date
- July 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Reason for Recall
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Distribution Pattern
US, Colombia, Philippines, Russia
Code Information
GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027