3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal
Summary
The FDA issued a Class II for 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to by 3M Company - Health Care Business. Reason: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M A.
Details
Source
Device Recall
External ID
Z-2639-2023
Action Date
2023-10-04
Status
Ongoing
Category
device
Product Description
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Lot/Code Info: 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
Quantity Affected: 172,464 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 132¿C and 135¿C.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-22
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
3M Company - Health Care Business has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (3M Company - Health Care Business) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 3M Company - Health Care Business have FDA actions?
3M Company - Health Care Business has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2639-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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