FDA Enforcement
Class II
Completed
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Recall: Z-1766-2018
·
Reported May 16, 2018
Enforcement
- Recall Number
- Z-1766-2018
- Event ID
- 79841
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Bard Peripheral Vascular Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 16, 2018
- Initiation Date
- February 8, 2018
- Classification Date
- May 9, 2018
- Address
- 1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States
Description
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Reason
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Code Info
Lot Number Unique Device Identifier (UDI) REAN0067 (01)00801741110825(17)170628(10)REAN0067 REAP0630 (01)00801741110825(17)170728(10)REAP0630 REAS2309 (01)00801741110825(17)171028(10)REAS2309 REAV2088 (01)00801741110825(17)171028(10)REAV2088 REAY0330 (01)00801741110825(17)171031(10)REAY0330 REBS1275 (01)00801741110825(17)180731(10)REBS1275 REBT1568 (01)00801741110825(17)181031(10)REBT1568 REBV0713 (01)00801741110825(17)181231(10)REBV0713
Distribution
Nationwide
Quantity
876 units