Class 2 Device Recall 3M" SteriVac" Gas Sterilizer/Aerators

• Date Initiated by Firm: March 17, 2014
• Date Posted: April 02, 2014
• Recall Status: Terminated on January 22, 2015
• Recall Number: Z-1318-2014
• Recall Event ID: 67716
• 510(K)Number: K941748 K902036 K812867
• Product Classification: Sterilizer, ethylene-oxide gas - Product Code FLF
• Product: 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL; ; The 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.
• Code Information: Model SKU Starting S/N Ending S/N 5XL 70-2007-2303-2 721115 721309 5XL 70-2007-2304-0 820174 820201 5XL 70-2007-2575-5 780066 780102 8XL 70-2006-8493-7 350136 350268 8XL 70-2006-8498-5 450016 450027 4XL 523122, 522205, 522502, 522287, 522655.
• Recalling Firm/ Manufacturer: 3M Company - Health Care Business; 3M Center 2510 Conway Ave , B# 275-5-W-6; Saint Paul MN 55144
• For Additional Information Contact: 3M Health Care Service Line; 800-228-3957
• Manufacturer Reason for Recall: Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20
• FDA Determined Cause: Device Design
• Action: 3M sent an "Urgent Medical Device Field Correction" letter dated March 6, 2014. The letter was sent to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are being notified because our records indicate you received a unit that contains the cartridge puncture assembly that is the subject of this field correction. 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. 3M's goal is to service the affected units with minimal disruption to your facility. Units manufactured outside of the dates November 10, 2006 to December 14, 2007 are not affected. .For Further Information contact 3M Health Care Service Line at 1-800-228-3957 or your local 3M representative.
• Quantity in Commerce: 73 US, 346 OUS
• Distribution: Worldwide Distribution - USA (nationwide) Distribution including the states of AL, AZ, CA,CO, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, NE, NJ, NY, NC, ND, OH, OK,OA, SC, TX, WA, WV and WI. and the countries of COLOMBIA, VENEZUELA, UAE, THAILAND, GERMANY, CHINA, KOREA, CANADA, JAPAN, RUSSIA, INDIA, POLAND, PERU, AUSTRIA, ISRAEL, INDONESIA, SPAIN, CHILE, MALAYSIA, SWITZERLAND, EL SALVADOR, ECUADOR, LEBANON, MEXICO, ARGENTINA, BULGARIA, TAIWAN, TURKEY,ROMANIA, GUATEMALA and NEW ZEALAND.
• 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.