Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3062-2024 — Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.

U.S. FDA — Device Enforcement · United States · 2024-07-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3062-2024
Date of alert
2024-07-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bard Peripheral Vascular Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00801741085451
Reported risk: Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.