Recall Z-0844-2015 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
| Date | Dec 22, 2014 (initiated Nov 4, 2014) |
| Status | Terminated |
| Reason | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. |
| Root cause | Nonconforming Material/Component |
| Action | A customer notification letter dated 11/21/2014 will be sent to all customers who purchased the STERRAD 50, STERRAD 100S, STERRAD 200, STERRAD 100NX, and STERRAD NX System Cassettes. The letter informs the customers of the problems identified and the actions to be taken. |
| Quantity | 19,978 units total (9,792 units in US) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030429 | STERRAD 200 STERILIZER Advanced Sterilization Products, Aug 18, 2003 |