POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
This recall has been completed (originally issued February 8, 2018).
- Company
- Bard Peripheral Vascular Inc
- Recall Initiated
- February 8, 2018
- Recall Number
- Z-1772-2018
- Quantity
- 15 units
- Firm Location
- Tempe, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Distribution
Nationwide
Lot / Code Info
Lot Number Unique Device Identifier (UDI) REAN0057 (01)00801741110887(17)170628(10)REAN0057 REAN0204 (01)00801741110887(17)170628(10)REAN0204 REAP0770 (01)00801741110887(17)170728(10)REAP0770 REBP0837 (01)00801741110887(17)180131(10)REBP0837
Root Cause
Error in labeling
Action Taken
The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."