Z-1766-2018 Class II

Recalled by Bard Peripheral Vascular Inc — Tempe, AZ

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
February 8, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
876 units

Product Description

POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362

Reason for Recall

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

Distribution Pattern

Nationwide

Code Information

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