3M" Steri-Vac" Gas Sterilizer/Aerators recall
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…
Why was 3M" Steri-Vac" Gas Sterilizer/Aerators recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 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.
- Recall date
- April 9, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)