Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. Sterili
FDA device recall Z-0597-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Midmark Corportation
- 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 taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FLE
- Quantity affected
- 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, MA
- Date initiated
- 2011-10-24
- Date posted
- 2012-01-11
- Date terminated
- 2014-06-20
- Location
- Versailles, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (K936181) | Midmark Corp. | 1994-11-30 |