POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling 876 units of the POWERPORT ClearVUE Implantable Port with Smooth Septum nationwide due to incorrect port flushing instructions printed on the Patient ID Card packaged with the device. The affected lots are identified by specific lot numbers and UDI codes ranging from REAN0067 through REBV0713, with expiration dates between June 2017 and December 2018.
The source document does not specify a remedy or recommended action 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: 876 units Lot/code info: Lot Number Unique Device Identifier (UDI) REAN0067 (01)00801741110825(17)170628(10)REAN0067 REAP0630 (01)00801741110825(17)170728(10)REAP0630 REAS2309 (01)00801741110825(17)171028(10)REAS2309 REAV2088 (01)00801741110825(17)171028(10)REAV2088 REAY0330 (01)00801741110825(17)171031(10)REAY0330 REBS1275 (01)00801741110825(17)180731(10)REBS1275 REBT1568 (01)00801741110825(17)181031(10)REBT1568 REBV0713 (01)00801741110825(17)181231(10)REBV0713
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.