Recall Z-0403-2014 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
| Date | Nov 26, 2013 (initiated Nov 11, 2013) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems. |
| Root cause | Labeling design |
| Action | Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notificaiton letter on November 11, 2013, to all affected customers. The letter informed customers of the problems identified and the actions to be taken. Customers were instructed to provide the notice to anyone in their facility that needs to be informed and post this notice where appropriate. Customers were instructed to contact ASP at 1-888-783-7723 for any suspected problems. ASP is collaborating with KARL STORZ Endoskope to determine the sterilization impact of the suction port lumen material. Customers are |
| Quantity | Total 4,381 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042116 | STERRAD NX STERILIZER Advanced Sterilization Products, Apr 22, 2005 |