Home / Recalls / Bard Peripheral Vascular Inc / Z-1760-2018

Z-1760-2018 Class II

Recalled by Bard Peripheral Vascular Inc — Tempe, AZ

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
February 8, 2018
Termination Date
N/A
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

Other recalls by Bard Peripheral Vascular Inc

  • Z-1367-2026 Class II — Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrow (December 12, 2025)
  • Z-0887-2026 Class II — Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, (November 6, 2025)
  • Z-2638-2025 Class II — Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identif (August 21, 2025)
  • Z-1244-2025 Class I — Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 11 (February 5, 2025)
  • Z-0467-2025 Class II — Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 C (September 30, 2024)
  • Z-0371-2025 Class II — The EVSRF catheter is a sterile, single-use disposable medical device for endove (September 4, 2024)
  • Z-3206-2024 Class II — BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 (August 2, 2024)
  • Z-3062-2024 Class II — Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for (July 10, 2024)
  • Z-0676-2024 Class II — BD Recanalization System, REF: BDRECANSYSTEM (November 14, 2023)
  • Z-0643-2024 Class II — Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission (November 8, 2023)