Z-1771-2018 Class II

Recalled by Bard Peripheral Vascular Inc — Tempe, AZ

FDA device recall Z-1771-2018 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: 181 units.

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
Feb 8, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
181 units

Product Description

POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301

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) REAN0061 (01)00801741110818(17)170628(10)REAN0061 REAP0772 (01)00801741110818(17)170728(10)REAP0772 REAT1524 (01)00801741110818(17)171128(10)REAT1524 REAV1479 (01)00801741110818(17)171228(10)REAV1479 REAV1938 (01)00801741110818(17)171028(10)REAV1938 REAW0937 (01)00801741110818(17)171031(10)REAW0937 REAW1186 (01)00801741110818(17)171031(10)REAW1186 REAW1666 (01)00801741110818(17)171031(10)REAW1666 REAY0528 (01)00801741110818(17)171031(10)REAY0528 REAY0795 (01)00801741110818(17)171031(10)REAY0795 REAZ1529 (01)00801741110818(17)171231(10)REAZ1529 REBN0024 (01)00801741110818(17)171231(10)REBN0024 REBN1581 (01)00801741110818(17)180131(10)REBN1581 REBQ0210 (01)00801741110818(17)180131(10)REBQ0210 REBS1277 (01)00801741110818(17)181031(10)REBS1277 REBR1125 (01)00801741110818(17)181031(10)REBR1125 REBS1395 (01)00801741110818(17)181031(10)REBS1395 REBS2412 (01)00801741110818(17)181130(10)REBS2412 REBT1785 (01)00801741110818(17)181231(10)REBT1785 REBT2349 (01)00801741110818(17)181231(10)REBT2349 REBU0563 (01)00801741110818(17)181231(10)REBU0563 REBV0760 (01)00801741110818(17)190228(10)REBV0760 REBW1037 (01)00801741110818(17)190331(10)REBW1037

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1771-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.