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Advanced Sterilization Products recalls Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
Recalled November 20, 2013 · FDA recall Z-0190-2014 · Advanced Sterilization Products
Hazard
Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps. · FDA Class II
Units
2106 units total (1224 units in US)
Sold at
Worldwide Distribution-USA (nationwide) and the countries of EMEA, APAC, Japan, Canada. AE, AU, BE, BH, CA, CH, CL, CN, CO, DE, EC, ES, GB, GR, HK, HU, IL, IN, IT, JP, KR, KW, MX, MY, NX, PA, PH, PK, PL, PR, QA, RU, SA, SG, SI, TH, VE, VN, ZA, and Tripoli.
Description
Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.
Product
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
Manufacturer(s)
Advanced Sterilization Products
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →