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U.S. Department of Health and Human Services

Class 2 Device Recall C1141 Processing Container

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  Class 2 Device Recall C1141 Processing Container see related information
Date Initiated by Firm April 23, 2003
Date Posted May 15, 2003
Recall Status1 Terminated 3 on February 05, 2004
Recall Number Z-0829-03
Recall Event ID 26151
510(K)Number k875280c  
Product Classification Sterilizer, Chemical - Product Code MLR
Product C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be sold individually or with the processing tray assembly (C1140).
Code Information All codes.
Recalling Firm/
Manufacturer		 Steris Corp
5960 Heisley Rd
Mentor OH 44060
Manufacturer Reason
for Recall		 The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
FDA Determined
Cause 2		 Other
Action The firm notified their customers by telephone and letter on 4/23/2003.
Quantity in Commerce 138 units
Distribution The product was shipped to end-users located nationwide and worldwide.
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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