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

Recall Z-2377-2021 — NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

U.S. FDA — Device Enforcement · United States · 2021-08-06 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2377-2021
Date of alert
2021-08-06
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Smiths Medical ASD Inc.
Product category
device
Product type
Devices
Reported risk: There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
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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