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U.S. Department of Health and Human Services

Class 2 Device Recall Midmark M11 Ultra Steam Sterilizer

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 Class 2 Device Recall Midmark M11 Ultra Steam Sterilizersee related information
Date Initiated by FirmOctober 24, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on June 20, 2014
Recall NumberZ-0597-2012
Recall Event ID 60456
510(K)NumberK936181 
Product Classification Sterilizer, steam - Product Code FLE
ProductMidmark 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 OH 45380
For Additional Information Contact
937-526-8297
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionMidmark 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 Commerce30,255 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FLE
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