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U.S. Department of Health and Human Services

Class 2 Device Recall STTERRAD 100NX Sterilizer

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 Class 2 Recall
STTERRAD 100NX Sterilizer
see related information
Date Posted November 08, 2013
Recall Status1 Terminated on January 16, 2014
Recall Number Z-0190-2014
Recall Event ID 66546
Product Classification Sterilizer, Chemical - Product Code MLR
Product Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
Code Information Batch 1041070019 1041080059 1041080056 1041080058 1041080055 1041080064 1041080063 1041080057 1041080060 1041070023 1041070022 1041080069 1041080070 1041080066 1041080068 1041080072 1041080073 1041080082 1041080077 1041080061 1041080074 1041080076 1041080078 1041080079 1041080081 1041080087 1041080071 1041080093 1041080080 1041080095 1041080090 1041080089 1041080088 1041080097 1041080098 1041080091 1041080099 1041080100 1041080101 1041080096 1041080159 1041080103 1041080102 1041080104 1041080160 1041080167 1041080172 1041080168 1041080169 1041080174 1041070049 1041070051 1041070048 1041080083 1041080086 1041080165 1041080173 1041080175 1041080164 1041080163 1041080180 1041080084 1041080182 1041080184 1041080189 1041080186 1041080191 1041080178 1041080177 1041080179 1041080185 1041080193 1041080197 1041080199 1041080188 1041080195 1041080198 1041080215 1041080194 1041080214 1041080260 1041080206 1041080205 1041080212 1041080204 1041080196 1041080203 1041080259 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Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Manufacturer Reason
for Recall
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 Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action A recall letter was sent to all customers on 10/18/13 who purchased the Sterrad 100NX Sterilizer. The letter informed the customers of the problems identified and the actions to be taken. Customers are instructed to contact ASP Professional Services directly at (888) 783-7723 and select option #2. Customers are instructed to report any complaints or suspected problems with their Sterrad 100NX System to Stericycle at (877) 598-5705.
Quantity in Commerce 2106 units total (1224 units in US)
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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