POWERPORT ClearVUE Slim with Smooth Septum recall
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
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) REAN0061 (01)00801741110818(17)170628(10)REAN0061 REAP0772 (01)00801741110818(17)170728(10)REAP0772 REAT1524 (01)00801741110818(17)171128(10)REAT1524 REAV1479 (01)00801741110818(17)171228(10)REAV1479 REAV1938 (01)00801741110818(17)171028(10)REAV1938 REAW0937 (01)00801741110818(17)171031(10)REAW0937 REAW1186 (01)00801741110818(17)171031(10)REAW1186 REAW1666 (01)00801741110818(17)171031(10)REAW1666 REAY0528 (01)00801741110818(17)171031(10)REAY0528 REAY0795 (01)00801741110818(17)171031(10)REAY0795 REAZ1529 (01)00801741110818(17)171231(10)REAZ1529 REBN0024 (01)00801741110818(17)171231(10)REBN0024 REBN1581 (01)00801741110818(17)180131(10)REBN1581 REBQ0210 (01)00801741110818(17)180131(10)REBQ0210 REBS1277 (01)00801741110818(17)181031(10)REBS1277 REBR1125 (01)00801741110818(17)181031(10)REBR1125 REBS1395 (01)00801741110818(17)181031(10)REBS1395 REBS2412 (01)00801741110818(17)181130(10)REBS2412 REBT1785 (01)00801741110818(17)181231(10)REBT1785 REBT2349 (01)00801741110818(17)181231(10)REBT2349 REBU0563 (01)00801741110818(17)181231(10)REBU0563 REBV0760 (01)00801741110818(17)190228(10)REBV0760 REBW1037 (01)00801741110818(17)190331(10)REBW1037
- Product
- POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 1411 units
- Distribution
- Nationwide
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)