FDA recall Z-3149-2024

Boston Scientific Corporation · Class II · device

Product

Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.

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-3149-2024