Recall Z-0597-2012 ยท FLE Sterilizer, Steam
Midmark Corportation
Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. Sterilize reusable equipment that is heat and moisture stable.
| Date | Jan 11, 2012 (initiated Oct 24, 2011) |
| Status | Terminated |
| Reason | During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning. |
| Root cause | Employee error |
| Action | Midmark Corp. will begin sending customer communications out the week of January 9, 2012 to all affected customers. The letter will describe the product, problem, and actions to be taken by the customers. Additionally, a warning label and an illustration of where to place the label will be included with the letter. Customers may contact the firm at 1-800-643-6275. |
| Quantity | 30,255 units |
| Distribution | Worldwide Distribution- USA (nationwide) including Puerto Rico and the countries of AUSTRALIA, BELGIUM, BRAZIL, CHILE, CHINA, EGYPT, FRANCE, GUAM, HONG KONG, HUNGARY, ICELAND, INDIA, KOREA, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, POLAND, RUSSIA, SAIPAN MP, SAUDI ARABIA, SEOUL, SINGAPORE, TAIWAN, THAI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K936181 | MIDMARK M-11 ULTRACLAVE STEAM STERILIZER Midmark Corp., Nov 30, 1994 |