FDA recall Z-3150-2024

Boston Scientific Corporation · Class II · device

Product

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

US, Colombia, Philippines, Russia

Key facts

Status
Ongoing
Initiation date
2024-07-18
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3150-2024