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Terminated

QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the STERIS SYSTEM I Processor and the C1160 Universal Flexible Processing Tray. The QFC1631 is for Fujinon 450/485 Series Video Gastroscopes; The QFC1683 is for Fujinon EC-450LP Colonoscopes; The QFC1685 is for Fujinon 450/485 Series Video Colonoscopes with Water Jet;

FDA Recall Z-0724-03 · Posted 2003-04-16

Recalling FirmSteris Corp
Recall StatusTerminated
Product CodeMLR
Date Initiated2003-03-20
Date Terminated2004-02-05
Product Quantity46

Reason for Recall

The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope.

Firm Action

The firm contacted their affected consignees by telephone and letter on 3/20/2003.

Root Cause

Other

Distribution Pattern

The devices were shipped to hospitals located in ME, NB, CA, IL, NJ, OH, IL, TX, MA, GA, MO, NC, and FL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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