Recall Z-0765-04 ยท MED Sterilant, Medical Devices
Steris Corp
QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680
| Date | Jul 20, 2004 (initiated Mar 15, 2004) |
| Status | Terminated |
| Reason | A defective port adapter may affect the sterilization process of the attached endoscope. |
| Root cause | Process control |
| Action | The firm contacted the consignees by letter and in person. |
| Quantity | 40 units |
| Distribution | The product was shipped to domestic consignees in LA, NC, OH, CT, VA, CA, ME, MD, IL, PA, SC, WY, ND, NY, OK, TX. Foreign distribution involves: Canada, Italy, and Germany. |
| 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 |