STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
This recall has been terminated (originally issued October 22, 2013).
- Company
- Advanced Sterilization Products
- Recall Initiated
- September 18, 2013
- Posted
- October 22, 2013
- Terminated
- January 13, 2014
- Recall Number
- Z-0044-2014
- Quantity
- 2,995 units
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
Distribution
Nationwide Distribution
Lot / Code Info
Lot# 13F050, 13F051, 13F049
Root Cause
Under Investigation by firm
Action Taken
Advanced Sterilization Products (ASP) sent an Urgent Medical Device Recall letter on September 18, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to examine their inventory and return all affected cassettes using the enclosed prepaid UPS return lave to Stericycle. Customers were asked to count their inventory and record the data on the enclosed Business Reply Card and Packing Slip. Customers were asked to provide the notice to anyone in their facility that needs to be informed. Customers were also asked to maintain a copy of the notice with the affected product. Customers with questions or suspected problems were instructed to contact Stericycle directly at 1-877-257-7119. For questions regarding this recall call 949-453-6400.