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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 Recall
Steris Quick Connects (QC) QFC1728 and QFC1729
see related information
Date Posted October 24, 2007
Recall Status1 Terminated on September 28, 2010
Recall Number Z-0101-2008
Recall Event ID 44810
Premarket Notification
510(K) Number
K875280 
Product Classification Sterilant, Medical Devices - 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, Ohio 44060-4307
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MED and Original Applicant = STERIS C/O MEDICAL DEVICE CONSULTANTS, INC.
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