3M Steri-Vac Gas Sterilizers Recalled for Ethylene Oxide Exposure Risk
3M is recalling Steri-Vac Gas Sterilizers due to a rare failure that could cause ethylene oxide exposure. The issue affects specific models manufactured in late 2006 and 2007.
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 exposure to Ethylene Oxide, a hazardous chemical, but only a single potential exposure report is cited without confirmed injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
3M Company - Health Care Business is recalling specific models of the 3M Steri-Vac Gas Sterilizer/Aerator, including models 4XL, 5XL, and 8XL. The recall is due to a single report of potential exposure to Ethylene Oxide (EO) at a hospital installation. The cause was traced to a rare failure of the EO cartridge puncture assembly, a component that was in production from November 10, 2006, through December 14, 2007.
The affected units were distributed worldwide, including in the United States and numerous international markets. The recall covers 73 units in the US and 346 units outside the US. Specific serial number ranges for the 5XL, 8XL, and 4XL models are listed in the official recall documentation.
Healthcare facilities and consumers should check their equipment serial numbers against the provided list. If a unit is affected, it should be removed from service. 3M is the recalling firm responsible for managing this safety action.
The recalled product
- Product
- 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.
- Manufacturer
- 3M Company - Health Care Business
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 (4)
- 522205
- 522502
- 522287
- 522655.
Distribution
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