Z-0649-2021Class II

ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water...

Name: Z-0649-2021 ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water...
Creator: Ga Health Company Limited
Published: 2020-11-03
License: https://open.fda.gov/license/

GA Health Company Limited / initiated 2020-11-03 / Terminated / root cause: manufacturing process

FDA source

GA HEALTH COMPANY LIMITED began a recall of ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4 on 2020-11-03. FDA classified it as Class II and gives the reason as "Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0649-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-03
Posted: 2020-12-18
Terminated: 2021-09-03
Recalling firm: GA Health Company Limited
Product: ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
Product code: OCX Endoscopic Irrigation/Suction System
Reason for recall: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 10,000 units
Distribution: US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Product codes and lots: Lot Numbers: 19122419 Unit UDI: 0810929043732 Box UDI: 10810929043739 Carton Box UDI: 20810929041640

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0649-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0639-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0640-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0641-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0642-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0643-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0644-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0645-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0646-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0647-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0648-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18
Z-0649-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-18

Product code OCX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)