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U.S. Department of Health and Human Services

Class 2 Device Recall Tabletop Steam Sterilizers.

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  Class 2 Device Recall Tabletop Steam Sterilizers. see related information
Date Initiated by Firm March 05, 2003
Date Posted April 01, 2003
Recall Status1 Terminated 3 on January 20, 2004
Recall Number Z-0704-03
Recall Event ID 25727
Product Classification Sterilizer, Steam - Product Code FLE
Product Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers.
Code Information Models: M7-011 and M7-014; Serial Numbers: MH006260 to MH006269, MH006273, MH006277 to MH006282, MH006284 to MH006290, MH006294, ML007606 to ML007608, ML007610, ML007637 to ML007642.
Recalling Firm/
Manufacturer		 Midmark Corp
60 Vista Dr
PO Box 286
Versailles OH 45380
Manufacturer Reason
for Recall		 The pressure relief valve may fail to open properly.
FDA Determined
Cause 2		 Other
Action The firm notified their customers by telephone on 3/5/2003.
Quantity in Commerce 35
Distribution The units were shipped to distributors and medical facilities located in: ME, IL, CA, VA, MA, MO, AZ, OH, IN, NH, and FL. The units were also distributed into Canada.
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.
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