Recall Z-0967-2007 ยท MED Sterilant, Medical Devices
Steris Corp
Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Water Jet. The QFC1729 is used to process 250/450 Group 5 and 530/590 series Endoscopes w/ Water Jet.
| Date | Jun 21, 2007 (initiated Feb 23, 2007) |
| Status | Terminated |
| Reason | The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope |
| Root cause | Process control |
| Action | On February 22, 2007, customers were contacted by phone and were notified by recall letter dated February 23, 2007. The recall notifications indicate that Steris Account managers will visit each consignee and replace affect product. |
| Quantity | 146 |
| Distribution | Worldwide-The product was distributed to USA domestic consignees located in MT, CA, NJ, IA, MA, WY, SC, MO, SC, TN, ID, MT, CO, PA, NV, and TX, and to foreign consignees located in Great Britian and Qatar. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.