POWERPORT ClearVUE Slim with Smooth Septum recall
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
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) 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
- Product
- POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 2835 units
- Distribution
- Nationwide
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)