Z-3150-2024 Class II Ongoing

Recalled by Boston Scientific Corporation — Maple Grove, MN

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