3M Steri-Vac Gas Sterilizer Valves Recalled for Labeling Error
3M is recalling 74 Steri-Vac Gas Sterilizer valves due to a labeling error that could cause incorrect installation and potential valve failure.
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: The recall involves a risk-of-harm product (medical device) where a defect could lead to chemical exposure, but the source describes the possibility as 'remote' and does not report any injuries or illnesses, fitting the High severity criteria for theoretical risk without reported harm.
Plain-English summary
3M Company - Health Care Business is recalling 74 valves for the 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. The recall is due to a defect where the "input" and "output" orientation labels on the valve are incorrectly marked.
This labeling error creates a remote possibility that the valve could be installed backwards. If installed incorrectly, the valve may fail, which could result in ethylene oxide (EO) being vented outside the sealed chamber during a limited period of the EO injection phase of the sterilization cycle.
The affected valves were distributed to 15 US states and 22 countries. Affected serial numbers for Model 5XL are 722612 - 722683 and 820352 - 820360. Affected serial numbers for Model 8XL are 351303 - 351399 and 450144 - 450147. Users should check their equipment serial numbers against this list and contact 3M for instructions on replacement or repair.
The recalled product
- Product
- 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
- Manufacturer
- 3M Company - Health Care Business
- Affected units
- 74
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)
- Model 5XL
- Serial Numbers: 722612 - 722683
- 820352 - 820360 Model 8XL
- Serial Numbers: 351303 - 351399
- 450144 - 450147
Distribution
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