Recall Z-1027-2013 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
| Date | Mar 30, 2013 (initiated Mar 22, 2013) |
| Status | Terminated |
| Reason | The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. |
| Root cause | Nonconforming Material/Component |
| Action | Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2. |
| Quantity | 1038 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030429 | STERRAD 200 STERILIZER Advanced Sterilization Products, Aug 18, 2003 |