Medical Device Recall: Z-0022-2013

FDA Recalls dataset · Firm: 3M Company Health Care Business 3M Center · Status: Terminated

Recall Action Class: N/A Date Initiated: 2012-09-13 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0022-2013.

Recall Res Number
Z-0022-2013
Recalling Firm / Manufacturer
3M Company Health Care Business 3M Center
FEI Number
2110898
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2012-09-13
Date Posted
2012-10-09
Date Terminated
2013-01-29
Product Code
FLF
Event Number
63214
Product Quantity
707 units (61 US, 646 OUS)
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.
Action Details 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. .
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.
Code Information / Serial Numbers Model 5XL 1-door, serial numbers from 721799 - 722166.  Model 5XL 2-door, serial numbers from 820248 - 820285.  Model 8XL 1-door, serial numbers from 350608 - 350887. Model 8XL 2-door, serial numbers from 450073 - 450105

Related Establishments / Registrations

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