Z-1769-2018 Class II
FDA device recall Z-1769-2018 was initiated by Bard Peripheral Vascular Inc on Feb 8, 2018 and is designated Class II. Reason for recall: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Affected quantity: 835 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Feb 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 835 units
Product Description
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
Reason for Recall
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Distribution Pattern
Nationwide
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1769-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026