Z-1764-2018 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
2835 units

Product Description

POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300

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) REAN0060 (01)00801741110801(17)170628(10)REAN0060 REAN1126 (01)00801741110801(17)170628(10)REAN1126 REAP0475 (01)00801741110801(17)170728(10)REAP0475 REAP0511 (01)00801741110801(17)170728(10)REAP0511 REAY0813 (01)00801741110801(17)171031(10)REAY0813 REAY0800 (01)00801741110801(17)171031(10)REAY0800 REBP1202 (01)00801741110801(17)180131(10)REBP1202 REBP1622 (01)00801741110801(17)180131(10)REBP1622 REBS1267 (01)00801741110801(17)180731(10)REBS1267 REBR1122 (01)00801741110801(17)180930(10)REBR1122 REBS1784 (01)00801741110801(17)180930(10)REBS1784 REBU1162 (01)00801741110801(17)181130(10)REBU1162 REBV1757 (01)00801741110801(17)190228(10)REBV1757 REBX1546 (01)00801741110801(17)190331(10)REBX1546 REBY0830 (01)00801741110801(17)190430(10)REBY0830