Recall Z-0661-2013 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
| Date | Jan 9, 2013 (initiated Sep 20, 2012) |
| Status | Terminated |
| Reason | Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life. |
| Root cause | Labeling design |
| Action | Advanced Sterilization Product sent an Urgent Medical Device Recall (Removal) letter dated December 4, 2012, to all affected customers. The letter informed the customers that the Sterrad NX Cassettes do not have adequate data to support the entire duration of the product's labeled shelf-life. Customers are instructed of the problems identifed and the actions to be taken. Customers are instructed to notify their customers if they have further distributed the recalled products and to have them contact Stericycle at (877) 650-7686 to arrange for return of the product. Customers with questio |
| Quantity | 12,280 units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.