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Terminated

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.

FDA Recall Z-0022-2013 · Posted 2012-10-09

Recalling Firm3M Company - Health Care Business
Recall StatusTerminated
Product CodeFLF
Date Initiated2012-09-13
Date Terminated2013-01-29
Product Quantity707 units (61 US, 646 OUS)

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.

Firm Action

3m Healthcare Service Center sent a Urgent Medical Device Field Correction letter dated September 19. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 3M will contact you to schedule an appointment for a field correction on any unit in the range of serial numbers provided in the table. 3Ms goal is to service the affected units with minimal disruption to your facility. We apologize for any inconvenience this field correction may cause. Please be assured that 3M is committed to the highest level of safety and customer service and we are proud of our longstanding safety record for 3M" Steri-Vac" Gas Sterilizers. For Further Information If you have any questions, please contact the 3M Health Care Service Line at 1-800-688-5888 or your local 3M representative. .

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K941748STERI-VAC GAS STERILIZER MODEL 8XL3M Health Care, Ltd. · 1994-12-02K902036STERI-VAC GAS STERILIZER MODEL 5XL3M Company · 1990-07-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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