Z-1761-2018 Class II
FDA device recall Z-1761-2018 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: 2395 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Feb 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2395 units
Product Description
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
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) REAN0058 (01)00801741110740(17)170628(10)REAN0058 REAN0205 (01)00801741110740(17)170628(10)REAN0205 REAN1124 (01)00801741110740(17)170628(10)REAN1124 REAP0769 (01)00801741110740(17)170728(10)REAP0769 REAT1312 (01)00801741110740(17)171128(10)REAT1312 REBP1357 (01)00801741110740(17)180131(10)REBP1357 REBR0999 (01)00801741110740(17)180731(10)REBR0999 REBV0758 (01)00801741110740(17)180930(10)REBV0758
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1761-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026