Recall Z-1632-2008 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive reusable medical devices.
| Date | Aug 8, 2008 (initiated Feb 25, 2008) |
| Status | Terminated |
| Reason | Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke." |
| Root cause | Device Design |
| Action | The firm sent an Urgent Device Correction letter dated 4/23/08, notifying customers of a situation that may occur with all models of STERRAD Sterilization Systems (100S, 50, 200, NX and 100NX). As a precaution, personnel should leave the room if mist is observed and avoid returning until the mist has cleared. ASP asks that customers circulate this letter to any STERRAD system users within their facility and also to the Chief Administrative Officer, the Director of Biomedical Engineering, Director of Materials Management and the Chief of Nursing. The letter instructs customers on what to do |
| Quantity | 9,950 |
| Distribution | Worldwide Distribution -- including USA and countries of France, Germany, Italy, United Kingdom, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Ireland, Israel, Japan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071385 | STERRAD 100NX STERILIZER Advanced Sterilization Products, Nov 29, 2007 |