Z-1767-2018 Class II
FDA device recall Z-1767-2018 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: 4044 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Feb 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4044 units
Product Description
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
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) REAN0059 (01)00801741110757(17)170628(10)REAN0059 REAN1125 (01)00801741110757(17)170628(10)REAN1125 REAP0627 (01)00801741110757(17)170728(10)REAP0627 REBN2011 (01)00801741110757(17)180131(10)REBN2011 REBP0853 (01)00801741110757(17)180131(10)REBP0853 REBS1276 (01)00801741110757(17)181031(10)REBS1276 REBS2291 (01)00801741110757(17)181130(10)REBS2291 REBU1357 (01)00801741110757(17)181231(10)REBU1357 REBW1455 (01)00801741110757(17)190331(10)REBW1455 REBY0778 (01)00801741110757(17)190430(10)REBY0778
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1767-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026