3M Attest Biological Indicators Cap May Melt During Sterilization
3M is recalling 77,280 Attest biological indicators due to caps that may melt, deform, or crack during steam sterilization cycles, potentially compromising process validation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a sterilization validation device. The manufacturing defect (cap melting, deformation, or cracking) creates a risk of compromised sterilization process validation. This qualifies as High severity under the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
3M Company is recalling specific lot codes of three Attest biological indicator product lines: the Attest Super Rapid Readout Biological Indicators (model 1492V), the Attest Super Rapid 5 Steam-Plus Challenge Pack (models 41482V and 41482VF), and the Attest Super Rapid Readout Steam Challenge (model 1496V). Affected lot codes include 41482VF with expiration code 33P4ND and lot 33P4YN with expiration 01/02/2025. The recall affects 77,280 devices total.
The recalled biological indicators may contain a cap that melts, deforms, or cracks when exposed to steam sterilization cycles at temperatures of 132°C or 135°C. If the cap is compromised in this manner, the biological indicator may not function properly and could fail to accurately validate the sterilization process.
The affected devices were 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. Healthcare facilities and sterilization service providers should identify any affected products by checking the lot codes against their inventory. Users should stop using the recalled lots and contact 3M Company - Health Care Business for further guidance.
The recalled product
- Product
- 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes
- Manufacturer
- 3M Company - Health Care Business
- Hazard
- cap-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI: 50707387787283( (shipper)
- Lot Codes: 41482VF
- exp. 33P4ND
- 33P4YN
- exp. 01/02/2025
Distribution
Distributed nationwide across the United States.
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