FDA Enforcement
Class II
Completed
POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
Recall: Z-1772-2018
·
Reported May 16, 2018
Enforcement
- Recall Number
- Z-1772-2018
- Event ID
- 79841
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Bard Peripheral Vascular Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 16, 2018
- Initiation Date
- February 8, 2018
- Classification Date
- May 9, 2018
- Address
- 1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States
Description
POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
Reason
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
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
Distribution
Nationwide
Quantity
15 units