Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunct

FDA device recall Z-0101-2008 · posted 2007-10-24 · Terminated

Recall details

Recalling firm

Steris Corporation Hopkins Facility

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.

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.

Root cause

Component design/selection

Status

Terminated

Product code

MED

Quantity affected

391 Quick Connects

Distribution

Worldwide: United States, Australia, Bahrain, Canada, Germany, Great Britain, Hungary, Italy, Qatar, and Spain

Date initiated

2007-09-12

Date posted

2007-10-24

Date terminated

2010-09-28

Location

Mentor, OH