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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 Sterilizer see related information
Date Initiated by Firm October 24, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on June 20, 2014
Recall Number Z-0597-2012
Recall Event ID 60456
510(K)Number K936181  
Product Classification Sterilizer, steam - Product Code FLE
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 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FLE and Original Applicant = MIDMARK CORP.
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