FDAClass IIOctober 4, 2023

3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack recall

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

Why was 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack recalled?

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 132¿C and 135¿C.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI: 50707387787276( (shipper); Lot Codes: 33P3EF, exp. 12/27/2024; 33P4ND, exp. 01/01/2025; 33P4NR, exp. 01/01/2025; 33P5CA, exp. 01/03/2025; 33P5XT, exp. 01/06/2025

Product
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Recalling firm
3M Company - Health Care Business
Quantity
172,464 devices
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.
Recall date
October 4, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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