| | Class 2 Recall
Midmark M11 Ultra Steam Sterilizer |  |
| Date Posted |
January 11, 2012 |
| Recall Number |
Z-0597-2012 |
| Product |
Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380.
Sterilize reusable equipment that is heat and moisture stable. |
| Code Information |
Model #'s: M11-001, M11D-001, M11-001R, M11D-002, M11-002, M11-002R, M11-003, M11-004, M-005, and M11-006
|
Recalling Firm/
Manufacturer |
Midmark Corportation
60 Vista Dr
Versailles, Ohio 45380 |
| Consumer Instructions |
Contact the recalling firm for information |
Reason for
Recall |
During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.
|
| 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 in Commerce |
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, THAILAND, TURKEY, U.A.E., UNITED KINGDOM and WEST INDIES. |
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