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

Recall Z-2395-2020 — BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP H965460171 H96546

U.S. FDA — Device Enforcement · United States · 2020-05-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2395-2020
Date of alert: 2020-05-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Angiodynamics, Inc.
Product category: device
Product type: Devices

Reported risk: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.

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.

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.

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