Recall Z-0043-2014 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
| Date | Oct 22, 2013 (initiated Sep 18, 2013) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. |
| Root cause | Under Investigation by firm |
| Action | A customer notification letter was sent on September 18, 2013, to all customers who received the STERRAD 200 Sterilization System. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to indicate if they have received a STERRAD 200 System and to report any complaints or suspected problems to Advanced Sterilization Products (ASP) Professional Services directly at (888) 783-7723 and select option #2. An alternate design for the oil mist filter is being developed and qualification of new vacuum pump oil is in process. This action is |
| Quantity | 1,305 units total (654 units in US , 651 OUS ) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030429 | STERRAD 200 STERILIZER Advanced Sterilization Products, Aug 18, 2003 |