Recall Z-2174-2013 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
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.
| Date | Sep 10, 2013 (initiated Jul 25, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 1,923 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071385 | STERRAD 100NX STERILIZER Advanced Sterilization Products, Nov 29, 2007 |