3M and Comply Sterilization Indicators Recalled for Temperature Excursions
Sterilization indicator products from Mckesson Medical-Surgical distributed nationwide may have been exposed to higher temperatures between June and August 2021. The temperature excursions may have impacted product effectiveness in verifying sterilization processes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with a theoretical hazard of reduced product effectiveness due to temperature exposure. No reported illnesses, injuries, or confirmed product failures. Per the rubric, Class III recalls are typically scored 1-2, and the precautionary nature of this temperature-exposure recall places it at the moderate level.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling sterilization indicator products including Comply Vapor Gas Indicator (3M Model 1248) and 3M Attest Chemical Vaporized Hydrogen Peroxide Indicator (Model 1348). These products are used to verify the effectiveness of sterilization processes in medical device sterilization.
The recall was issued due to temperature excursions that occurred at a facility from June 2021 through August 2021, prior to product delivery. Exposure to higher temperatures during storage or transport may have affected the products' ability to function as sterilization indicators.
All products distributed nationwide that were received between June 1, 2021, and September 30, 2021, are included in this recall. The affected products are supplied in quantities of 12 bags or 4 bags per case.
Healthcare facilities and sterilization services that received these products should identify any inventory from the affected time period. Any sterilization indicators from recalled lots should not be relied upon to verify sterilization effectiveness without further evaluation. Facilities should contact Mckesson Medical-Surgical or the FDA for guidance on affected lot numbers and recommended actions.
The recalled product
- Product
- a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- effectiveness-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- GTIN: a. 00707387508296
- 00707387457037
- 50707387508291
- 30707387508297
- 30707387457038. b. 50707387788006
- 30707387788002
- 00707387788001.
Distribution
Distributed nationwide across the United States.
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