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[Recalled] 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes — Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Product3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes
Brand / manufacturer3M Company - Health Care Business
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2640-2023
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date22 August 2023
EAN / barcode50707387787283

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from 3M Company - Health Care Business

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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