3M Attest Sterilization Indicator Caps May Melt or Crack

Plain-English summary

3M Company is recalling 172,464 units of specific lot codes of Attest Super Rapid Readout Biological Indicators, Attest Super Rapid 5 Steam-Plus Challenge Packs, and Attest Super Rapid Readout Steam Challenge biological indicators. These devices are used to monitor and validate steam sterilization processes. The recall is due to potential defects in the caps of these biological indicators.

During steam sterilization cycles at temperatures of 132°C and 135°C, the caps of affected units may melt, deform, and/or crack. This defect could compromise the integrity and function of the biological indicators.

The affected products have been distributed worldwide, including throughout the United States and to Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, and Taiwan. Specific affected lot codes with expiration dates are: 33P3EF (exp. 12/27/2024), 33P4ND (exp. 01/01/2025), 33P4NR (exp. 01/01/2025), 33P5CA (exp. 01/03/2025), and 33P5XT (exp. 01/06/2025).

If you have purchased or are using affected products, contact 3M for guidance on whether your product is included in this recall. Do not use affected units for sterilization validation until you have confirmed whether your product is recalled.

The recalled product

Product

3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes

Manufacturer

3M Company - Health Care Business

Category

Medical Device — Sterilization validation indicator

Hazard

• product-defect
• malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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