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Open, Classified

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

FDA Recall Z-2640-2023 · Posted 2023-09-26

Recalling Firm3M Company - Health Care Business
Recall StatusOpen, Classified
Product CodeFRC
Date Initiated2023-08-22
Product Quantity77,280 devices

Reason for Recall

Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C.

Firm Action

3M issued an Urgent product recall notice to its consignees on 08/24/2023 by email and US mail. The notice explained the problem with the product and requested the following: Discontinue distribution of the product and dispose of the product. Distributors were directed to notify their customers. The firm is offering replacement with the return of the completed response form.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1931543M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company · 2020-02-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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