FDA-Device2013-12-11Class III
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transport
Advanced Sterilization Products
Hazard
Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers.
Sold states
Worldwide Distribution - USA (nationwide) and the countries of Australia, Vietnam, Thailand, Malaysia, China, Korea (South), Mexico, Spain, Singapore, Hong Kong and Portugal.
Affected count
267 units total (252 units in US)
Manufactured in
33 Technology Dr, N/A, Irvine, CA, United States
Products
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0434-2014Don't want to check this manually?
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