Z-3150-2024 Class II Ongoing
FDA device recall Z-3150-2024 was initiated by Boston Scientific Corporation on July 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: 4 units.
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
- 4 units
Product Description
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
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 0871472913774, Lot # 33512377, exp. 02/26/2027