Recall Z-0746-2014 ยท FLF Sterilizer, Ethylene-Oxide Gas
Advanced Sterilization Products
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
| Date | Jan 14, 2014 (initiated Dec 16, 2013) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. |
| Root cause | Under Investigation by firm |
| Action | Advanced Sterilization Products (ASP) sent an Urgent Medical Device Field Safety Notification dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the customer response forms. Customers with questions were also instructed to contact ASP Professional Services directly at (888) 783-7723 and select option number 2. For questions regarding this recall call 949-453-6400. |
| Quantity | 2366 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023290 | STERRAD 50 & STERRAD 100S STERILIZERS Advanced Sterilization Products, Apr 3, 2003 |