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.
This recall has been terminated (originally issued October 24, 2007).
- Recall Initiated
- September 12, 2007
- Posted
- October 24, 2007
- Terminated
- September 28, 2010
- Recall Number
- Z-0101-2008
- Quantity
- 391 Quick Connects
- Firm Location
- Mentor, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide: United States, Australia, Bahrain, Canada, Germany, Great Britain, Hungary, Italy, Qatar, and Spain
Lot / Code Info
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
Root Cause
Component design/selection
Action Taken
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.