FDAClass IIMay 16, 2018

POWERPORT ClearVUE Slim with Smooth Septum recall

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

Why was POWERPORT ClearVUE Slim with Smooth Septum recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number Unique Device Identifier (UDI) REAN0065 (01)00801741110788(17)170628(10)REAN0065 REAP0473 (01)00801741110788(17)170728(10)REAP0473 REAX1813 (01)00801741110788(17)180430(10)REAX1813 REAZ0278 (01)00801741110788(17)180331(10)REAZ0278 REBS1438 (01)00801741110788(17)180930(10)REBS1438 REBT1881 (01)00801741110788(17)180930(10)REBT1881

Product
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
Recalling firm
Bard Peripheral Vascular Inc
Quantity
216 units
Distribution
Nationwide
Recall date
May 16, 2018
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls