FDA Medical Device Recalls (openFDA)
Steris Corp: 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;
- Recall number
- Z-0724-03
- Recalling firm
- Steris Corp
- 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;
- Status
- Terminated
- Initiated
- 2003-03-20
- Posted
- 2003-04-16
- Terminated
- 2004-02-05
- Reason
- The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope.
- Root cause
- Other
- Action
- The firm contacted their affected consignees by telephone and letter on 3/20/2003.
- Quantity
- 46
- Distribution
- The devices were shipped to hospitals located in ME, NB, CA, IL, NJ, OH, IL, TX, MA, GA, MO, NC, and FL.
- Lot, serial or model codes
- QFC1685 - Lots #3136314, #3136298, #3967981; QFC1683 - Lot #3136330; QFC1631 - Lot #4054870.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MLR
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28