Recall Z-0640-2021 ยท OCX Endoscopic Irrigation/Suction System
GA HEALTH COMPANY LIMITED
STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1
| Date | Nov 3, 2020 |
| Status | Terminated |
| Reason | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| Root cause | Process control |
| Action | GA Health Company Limited ( referred to as GA Health) issued URGENT: MEDICAL DEVICE RECALL notification letters is sent to affected direct consignees via email on 11/3/20 . The letter sent together with Recall Notice to Physician and Acknowledgement and Receipt Form which allows direct consignee to distribute to customer and collects feedback from direct consignee respectively. Actions to be Taken by the Distributor To facilitate quarantine of affected lots, GA Health recommends the following: " Review the device model and lot number below to identify and quarantine stock remained in your |
| Quantity | 25,000 units |
| Distribution | US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI. |
| FDA record | Open on fda.gov |