Recall Z-0022-2013— 3M Company - Health Care Business
Class II · Terminated
Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2012-09-13, terminated 2013-01-29. It names 2 FDA 510(k) clearances: K941748, K902036. Product: 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 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.. Reason: 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim..
- Recalling firm
- 3M Company - Health Care Business
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-13
- Terminated
- 2013-01-29
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 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.
Reason for recall
3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim.
Data sourced from openFDA. This site is unofficial and independent of the FDA.