FDA Enforcement
Class II
Ongoing
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Recall: Z-3147-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3147-2024
- Event ID
- 95186
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2024
- Initiation Date
- July 18, 2024
- Classification Date
- September 13, 2024
- Address
- 1 Scimed Pl, Maple Grove, MN, 55311-1565, United States
Description
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Reason
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Code Info
a) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027
Distribution
US, Colombia, Philippines, Russia
Quantity
89 units