Recall Z-0998-2013 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
| Date | Mar 26, 2013 (initiated Mar 13, 2012) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied. |
| Root cause | Device Design |
| Action | Advanced Sterilization Products (ASP) sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 13, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter informed the customers that ASP recently determined that the push bar located on the STERRAD 200 System Carriage can potentially become dislodged when an excessive load is applied. Customers with questions are instructed to contact Stericycle at (877) 931-0642. |
| Quantity | 2,457 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030429 | STERRAD 200 STERILIZER Advanced Sterilization Products, Aug 18, 2003 |