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

Recall Z-0115-2024 — HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

U.S. FDA — Device Enforcement · United States · 2023-08-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0115-2024
Date of alert
2023-08-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Access Vascular, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00850030354068
Reported risk: Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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.