Class 2 Device Recall 3M SteriVacGas Sterilizer/Aerator

• Date Initiated by Firm: January 22, 2016
• Create Date: April 24, 2016
• Recall Status: Terminated 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/ Manufacturer: 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; 800-228-3957
• 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: 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.