FDA-Device2012-09-12Class III
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Steris Corporation
Hazard
On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
Sold states
Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of Japan, Peru, and Suriname.
Affected count
77 packs
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2325-2012Don't want to check this manually?
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