POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling 835 units of the POWERPORT ClearVUE Slim Implantable Port with Smooth Septum nationwide due to incorrect port flushing instructions printed on the Patient ID Card packaged with the device. The affected units are identified by specific lot numbers ranging from REAN0066 through REBY1231, with expiration dates between May 2017 and April 2019.
The Patient ID Card contains flushing instructions that do not match the correct procedure for this particular port model. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Reason for recall: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Distribution: Nationwide Quantity: 835 units Lot/code info: Lot Number Unique Device Identifier (UDI) REAN0066 (01)00801741110795(17)170528(10)REAN0066 REAP0629 (01)00801741110795(17)170728(10)REAP0629 REAY1483 (01)00801741110795(17)180531(10)REAY1483 REAY2494 (01)00801741110795(17)180331(10)REAY2494 REBS0163 (01)00801741110795(17)181031(10)REBS0163 REBT0364 (01)00801741110795(17)181130(10)REBT0364 REBT1664 (01)00801741110795(17)181231(10)REBT1664 REBT2149 (01)00801741110795(17)181231(10)REBT2149 REBW0874 (01)00801741110795(17)190331(10)REBW0874 REBY1231 (01)00801741110795(17)190430(10)REBY1231
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.