FDA Device

STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.

Hazard

Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.

What You Should Do

Remedy

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.

Products

STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Brand
Advanced Sterilization Products
UPC
N/A

Units Affected

2,457 units