Z-1760-2018 Class II
FDA device recall Z-1760-2018 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: 359 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Feb 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 359 units
Product Description
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
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) REAN0063 (01)00801741110726(17)170628(10)REAN0063 REAN1123 (01)00801741110726(17)170628(10)REAN1123 REAP0467 (01)00801741110726(17)170728(10)REAP0467 REAY1733 (01)00801741110726(17)180331(10)REAY1733 REBS1266 (01)00801741110726(17)180731(10)REBS1266 REBV1731 (01)00801741110726(17)181231(10)REBV1731 REBX1626 (01)00801741110726(17)190331(10)REBX1626 REBY0777 (01)00801741110726(17)190430(10)REBY0777
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1760-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026