Recall Z-0340-2009 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
| Date | Nov 21, 2008 (initiated Oct 17, 2008) |
| Status | Terminated |
| Reason | 1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide sterilant and 2) Inability of the sterilizer to detect an obstruction in the door travel path while the door is closing. This situation can result in a hand b |
| Root cause | Component design/selection |
| Action | Customer notifications will be sent the week of November 24, 2008. The notification letter (URGENT: Product Correction) will advise of two situations that could cause the STERRAD 100S Sterilizer to malfunction. The first situation involves the failure of the STERRAD 100S System to detect when an injection takes place without hydrogen peroxide having been transferred to the vaporizer bowl. This can occur under combinations of the following conditions: - the pneumatic pressure is low on the machine, or - the injector valve has a small leak, AND - a cassette fails to advance, or - a used casse |
| Quantity | In the U.S., there are 2,623 units installed. There are also 3,701 units internationally. |
| Distribution | Worldwide Distribution including USA and countries of France, Germany, Italy, UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Israel, Japan, Korea, Malaysia, Singapo |
| FDA record | Open on fda.gov |