FDA recall Z-3147-2024

Product

Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose 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

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-3147-2024