GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

Recommended Action

Per FDA guidance

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 warehouse. Send the Recall Notice to Physician if you have already distributed the device to hospitals or clinics. " Return the Acknowledgement and Receipt Form to us within 7 calendar days upon receipt of this letter. " Discard the affected stock in you and your customers warehouse. Have the customers return any affected product to you, discard it also in your warehouse within 30 days upon receipt of this letter. " To discard the product, complete the enclosed RMA Form and complete scrap declaration. Return these two documents to your GA Health sales representative at lewis@gahealth.net within 30 days upon receipt of this letter. This will allow us to document the amount of product you will scrap for follow up arrangement. Should you have questions about this issue, contact lewis@gahealth.net or by phone at +852 2833 9010.