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

Recall Z-1313-2024 — Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"

U.S. FDA — Device Enforcement · United States · 2024-01-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1313-2024
Date of alert
2024-01-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mckesson Medical-Surgical Inc. Corporate Office
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10724995220072
Reported risk: Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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