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DeRoyal
DEROYAL INDUSTRIES, INC. · Model 54-5115R · UDI-DI 00749756767828
10
510(k) clearances
1,266
Adverse events (79 deaths)
24
Recalls
46
Facilities
Description
Enteral Safe 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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Get your free API keyRead the docsData 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.