Device product
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Z-3147-2024
Product summary
- Event
- Event 95186
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 89 units
- Official record key
device-enforcement:Z-3147-2024
Official wording
Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Code information: a) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027
Distribution pattern: US, Colombia, Philippines, Russia
Derived failure modes
-
Unknown
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.