Agency classClass IIOur severity:High FDA (Devices)·Z-1563-2016·Announced 2016-05-04

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Sterilization Equipment
Hazard: mis-labeling
chemical-exposure
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

Distributed in 15 states:

Same manufacturer · 3M Company - Health Care Business

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