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U.S. Department of Health and Human Services

Class 2 Device Recall 3M SteriVacGas Sterilizer/Aerator

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  Class 2 Device Recall 3M SteriVacGas Sterilizer/Aerator see related information
Date Initiated by Firm January 22, 2016
Create Date April 24, 2016
Recall Status1 Terminated 3 on August 25, 2016
Recall Number Z-1563-2016
Recall Event ID 73117
510(K)Number K902036  K941748  
Product Classification Sterilizer, ethylene-oxide gas - Product Code FLF
Product 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Code Information Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360  Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147
Recalling Firm/
3M Company - Health Care Business
3m Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144-0001
For Additional Information Contact 3M Health Care Service
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 74 valves
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FLF and Original Applicant = 3M COMPANY
510(K)s with Product Code = FLF and Original Applicant = 3M HEALTH CARE, LTD.