Z-3148-2024 Class II Ongoing
FDA device recall Z-3148-2024 was initiated by Boston Scientific Corporation on Jul 18, 2024 and is designated Class II. Reason for recall: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. The recall status is ongoing. Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 25, 2024
- Initiation Date
- Jul 18, 2024
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3148-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026