STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD
FDA device recall Z-0998-2013 · posted 2013-03-26 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 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 Re
- Date initiated
- 2012-03-13
- Date posted
- 2013-03-26
- Date terminated
- 2014-05-28
- Location
- Irvine, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD 200 STERILIZER (K030429) | Advanced Sterilization Products | 2003-08-18 |