Recall Z-2338-2012 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and 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 Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette mo
| Date | Sep 7, 2012 (initiated Jun 19, 2012) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing. |
| Root cause | Error in labeling |
| Action | Advanced Sterilization Products sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated July 16, 2012 to all their customers who purchased the STERRAD 100S and STERRAD NX System cassettes. The letter informed the customers of the problem identified and the actions to be taken. For the STERRAD NX System cassettes, there should be no impact to the functionality of these affected cassettes. Although printing may be smeared, illegible, or missing, the packaging has multiple references to the information, and the cassettes should be usable despite any printing error. For the STERRAD 100S S |
| Quantity | 7,550 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042116 | STERRAD NX STERILIZER Advanced Sterilization Products, Apr 22, 2005 |