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Terminated

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.

FDA Recall Z-1318-2014 · Posted 2014-04-02

Recalling Firm3M Company - Health Care Business
Recall StatusTerminated
Product CodeFLF
Date Initiated2014-03-17
Date Terminated2015-01-22
Product Quantity73 US, 346 OUS

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K941748STERI-VAC GAS STERILIZER MODEL 8XL3M Health Care, Ltd. · 1994-12-02K902036STERI-VAC GAS STERILIZER MODEL 5XL3M Company · 1990-07-19K812867STERI-VAC #400C GAS STERILIZER3M Company · 1981-11-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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