medical Class II Updated 2018-05-16

Bard Peripheral Vascular Inc recalls POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Po

Recalled Product

POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number Unique Device Identifier (UDI) REAN0059 (01)00801741110757(17)170628(10)REAN0059 REAN1125 (01)00801741110757(17)170628(10)REAN1125 REAP0627 (01)00801741110757(17)170728(10)REAP0627 REBN2011 (01)00801741110757(17)180131(10)REBN2011 REBP0853 (01)00801741110757(17)180131(10)REBP0853 REBS1276 (01)00801741110757(17)181031(10)REBS1276 REBS2291 (01)00801741110757(17)181130(10)REBS2291 REBU1357 (01)00801741110757(17)181231(10)REBU1357 REBW1455 (01)00801741110757(17)190331(10)REBW1455 REBY0778 (01)00801741110757(17)190430(10)REBY0778
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