Recall Z-0724-03 ยท MLR Sterilizer, Chemical
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;
| Date | Apr 16, 2003 (initiated Mar 20, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.