3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
FDA Recall Z-1563-2016 · Posted None
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Recalling Firm3M Company - Health Care Business
Recall StatusTerminated
Product CodeFLF
Date Initiated2016-01-22
Date Terminated2016-08-25
Product Quantity74 valves
Reason for Recall
3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.
Firm Action
3M sent an Urgent Medical Device Field Correction letter to customers beginning 01/22/2016. The letter identified affected product, and stated that a 3M Service representative will contact the consignee to inspect the sterilizer. Questions can be directed to 3M Health Care Service Line at 1-800-228-3957.
Root Cause
Nonconforming Material/Component
Distribution Pattern
AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include: Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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