Recall Z-2462-2008 ยท MED Sterilant, Medical Devices
Steris Corp
Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K SERIES GI ENDOSCOPES WITH WATER JET to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System. The QPC1713 is used to attach Pentax 70/70K/80K/85/85K/90K SERIES GI ENDOSCOPES without WATER JET to t
| Date | Sep 23, 2008 (initiated Aug 4, 2008) |
| Status | Terminated |
| Reason | During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barblock may interfere with the top surface of bottom barb of the adapter. The interference may cause the plunger on the suction side to lift slightly which may affect flow of sterilant into the suction lumen. |
| Root cause | Device Design |
| Action | A Steris Field Service Representative will make arrangements to visit each facility to modify the affected Quick Connects. Until that time customers may use the work around instructions for use in the notification letter dated August 4, 2008. Contact Steris Corporation at 1-800-548-4873 or 1-440-392-7455 for assistance. |
| Quantity | QPC1713 Quick Connects - 116 units & QPC1724 Quick Connects - 568 units |
| Distribution | AK, AL, AR, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, VA, VT, WI, WV and WY. OUS: Canada, Australia, Italy, Spain, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K875280 | STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT Steris C/O Medical Device Consultants, Inc., Sep 13, 1988 |