STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
This recall has been terminated (originally issued March 26, 2013).
- Company
- Advanced Sterilization Products
- Recall Initiated
- March 13, 2012
- Posted
- March 26, 2013
- Terminated
- May 28, 2014
- Recall Number
- Z-0998-2013
- Quantity
- 2,457 units
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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.
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.
Root Cause
Device Design
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.