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Ameritus

KENTEC MEDICAL, INC. · Model AEG-Y50P-80 · UDI-DI 10817522012131

FPD Prescription

510(k) clearances

1,266

Adverse events (79 deaths)

Recalls

Facilities

Description

5fr 80cm dual port feeding tube

Recalls

Date	Firm	Reason
2022-08-01	ICU Medical, Inc.	Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
2020-01-17	Kentec Medical, Inc	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, unti
2020-01-17	Kentec Medical, Inc	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, unti
2020-01-17	Kentec Medical, Inc	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, unti
2020-01-17	Kentec Medical, Inc	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, unti
2020-01-17	Kentec Medical, Inc	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, unti
2020-01-17	Kentec Medical, Inc	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, unti
2020-01-17	Kentec Medical, Inc	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, unti
2019-07-22	DeRoyal Industries Inc	Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
2019-07-16	Canadian Hospital Specialties	The firm received a complaint that the connector detached from the feeding tube.

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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.