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STOPCON Suction Valve-Suction Valve for GI-Endoscope recallZ-0642-2021 · Ga Health Company Limited · initiated Nov 3, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ga Health Company Limited or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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 [email protected] 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 [email protected] or by phone at +852 2833 9010.

Recall details

Recall number
Z-0642-2021
Status
Terminated
Initiated by the company
Nov 3, 2020
Recalling firm
Ga Health Company Limited
Quantity
10,000
Product code
OCX
FDA submissions
K181509, K182998
Distribution
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.

Product description

STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232

Code information (models, lots, serial numbers)

Lot Numbers: 19121826 Unit UDI: 04897106951178 Box UDI: 14897106951175 Cartoon Box UDI: 24897106951172

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 86763).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page