Z-0724-03

QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the...

Name: Z-0724-03 QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the...
Creator: Steris Corp
Published: 2003-03-20
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2003-03-20 / Terminated / root cause: sterility

FDA source

Steris Corp began a recall of QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal endoscopes, for use with the STERIS SYSTEM I Processor and the C1160 Universal... on 2003-03-20. The reason FDA records is "The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0724-03
Status: Terminated
Initiated: 2003-03-20
Posted: 2003-04-16
Terminated: 2004-02-05
Recalling firm: STERIS Corporation
Product: 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;
Product code: MLR Sterilizer, Chemical
Reason for recall: The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope.
Root cause tag: sterility
FDA root cause: Other
Action: The firm contacted their affected consignees by telephone and letter on 3/20/2003.
Quantity in commerce: 46
Distribution: The devices were shipped to hospitals located in ME, NB, CA, IL, NJ, OH, IL, TX, MA, GA, MO, NC, and FL.
Product codes and lots: QFC1685 - Lots #3136314, #3136298, #3967981; QFC1683 - Lot #3136330; QFC1631 - Lot #4054870.

Product code MLR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)