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U.S. Department of Health and Human Services

Class 2 Device Recall Andorate/STOPCON Disposable Endoscope Valves Set

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  Class 2 Device Recall Andorate/STOPCON Disposable Endoscope Valves Set see related information
Date Initiated by Firm November 03, 2020
Create Date December 18, 2020
Recall Status1 Terminated 3 on September 03, 2021
Recall Number Z-0647-2021
Recall Event ID 86763
510(K)Number K181509  K182998  
Product Classification endoscopic irrigation/suction system - Product Code OCX
Product Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector
Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA

Product Code: 1203-72
Code Information Lot Numbers: 20B10B, 20G10A Unit UDI: 0816734021347 Box UDI: 10816734021344 Cartoon Box UDI: 20816734021341    
Recalling Firm/
Manufacturer		 GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR
Manufacturer Reason
for Recall		 Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 20,000 units
Distribution US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OCX and Original Applicant = Smartdata Suzhou Co., Ltd
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