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Disposable Polypectomy Cold Snare

Yangzhou Fartley Medical Instrument Technology Co., Ltd · Model FTL-PSC-24-230-25-15-R · UDI-DI 06970900855885

FGX Prescription

510(k) clearances

572

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2022-10-24	Endo-Therapeutics, Inc.	Improper device regulatory classification
2021-10-29	Diversatek Healthcare	M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package
2021-01-04	Aomori Olympus Co., Ltd.	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
2021-01-04	Aomori Olympus Co., Ltd.	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
2021-01-04	Aomori Olympus Co., Ltd.	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
2021-01-04	Aomori Olympus Co., Ltd.	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
2021-01-04	Aomori Olympus Co., Ltd.	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
2021-01-04	Aomori Olympus Co., Ltd.	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
2021-01-04	Aomori Olympus Co., Ltd.	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
2021-01-04	Aomori Olympus Co., Ltd.	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.