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U.S. Department of Health and Human Services

Class 2 Device Recall Steris Quick Connects (QC) QFC1728 and QFC1729

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  Class 2 Device Recall Steris Quick Connects (QC) QFC1728 and QFC1729 see related information
Date Initiated by Firm September 12, 2007
Date Posted October 24, 2007
Recall Status1 Terminated 3 on September 28, 2010
Recall Number Z-0101-2008
Recall Event ID 44810
510(K)Number K875280C  
Product Classification Steris Quick Connects - Product Code MED
Product Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope.
Code Information C041782, C041793, 3072287, C041514, C041512, C041508, C041513, C041515, 3072303, 3290749, 3338126, C041781, C041794, 3072246, C041506, C041509, C041510, C041511, 3072261, 3290723, 3318292, 3338100, 3352374, 3542412, 3643871, 3546157, 3656121, 3893160, 3890027, 3748456, 3930062, 3978731, 3342342, 3352390, 3575941, 3643897, 3668357, 3895661, 3900198
Recalling Firm/
Manufacturer		 Steris Corporation Hopkins Facility
6515 Hopkins Rd
Mentor OH 44060-4307
For Additional Information Contact
440-392-7601
Manufacturer Reason
for Recall		 Loose or missing adaptor: The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor's housing. The absence of adaptor #6's center insert may affect the sterilization process of the attached endoscope.
FDA Determined
Cause 2		 Component design/selection
Action STERIS has contacted affected direct accounts by phone to notify direct accounts of the recall. On 9/28/2007, STERIS will mail a recall notification to all affected direct accounts via certified mail. The notification informs direct accounts that STERIS representatives will be visiting direct accounts to retrieve affected products and provide replacements. Where direct accounts further distribute, STERIS representatives will inform the direct accounts to contact their sub-accounts and facilitate exchange of affected product for replacement product. Replacement product will be available beginning November 1, 2007.
Quantity in Commerce 391 Quick Connects
Distribution Worldwide: United States, Australia, Bahrain, Canada, Germany, Great Britain, Hungary, Italy, Qatar, and Spain
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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