STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
FDA Recall Z-2174-2013 · Posted 2013-09-10
Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMLR
Date Initiated2013-07-25
Date Terminated2013-11-27
Product Quantity1,923 units
Reason for Recall
The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life.
Firm Action
ASP sent an Urgent Medical Device Field Safety Notification letter dated July 25, 2013, to all affected customers. The recall letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to contact Stericycle directly at (866) 562-5937 to report any complaints or suspected problems with their STERRAD 100NX System cassette. For questions regarding this recall call 949-453-6400.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - USA (nationwide) and internationally to RU, VE, KW, SA, HU, GB, IT, HK, IL, MX, ZA, PH, GR, AE, IN, CO, KR, AU, IN, ES, SG, MY, TH, TR, TW, SI, BE, PL, EC, CN, JP, PA, DE, VN, CL, and Switzerland, United Kingdom. Israel. Slovenia, Qatar, Panama, Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.