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HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004 — recall Z-1156-2023

U.S. FDA — Device Enforcement · United States · 2022-12-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1156-2023
Date of alert: 2022-12-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Access Vascular, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00850030354020

Reported risk: Label with the incorrect component listed on the inner kit Tyvek header bag

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004 — recall Z-1156-2023

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