Corpak Medsystems
Country not established
- Devices
- 517
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Corpak Medsystems makes
Corpak Medsystems manufactures enteral feeding devices, including nasogastric and jejunostomy tubes, gastrostomy buttons and tubes, and sterile enteral feeding kits for adults and children. Their portfolio also includes ultraviolet phototherapy units for professional use and electromagnetic tracking systems for locating enteral tubes, such as stylets and transmitters. Some products combine feeding tubes with retention systems or controllers for enhanced placement and stability.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) database. These products are designed for medical use in the United States, adhering to applicable regulatory standards for enteral nutrition and phototherapy equipment.
Catalogue
Search and filter all 517 devicesShowing 1-50 of 517
FDA recalls
FDA recall records list 5 recalls initiated by Corpak Medsystems, the earliest on 2011-09-19 and the most recent on 2017-02-03. By recorded status: 5 terminated. The reasons filed fall into these groups: packaging and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 3
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 3 Feb 2017 Z-2161-2017 Class II Terminated Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Full distribution text
- 3 Feb 2017 Z-2162-2017 Class II Terminated Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Full distribution text
- 3 Feb 2017 Z-2163-2017 Class II Terminated Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Full distribution text
- 3 Feb 2017 Z-2161-2017 Class II Terminated Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
2012
- 26 Jan 2012 Z-1080-2012 Not yet classified Terminated The wrong size Twoomey adapter was packaged with the Jejunal tube.
Full distribution text
- 26 Jan 2012 Z-1080-2012 Not yet classified Terminated The wrong size Twoomey adapter was packaged with the Jejunal tube.
2011
- 19 Sep 2011 Z-0089-2012 Unclassified (pre-2012) Terminated Corpak is removing the Corflo 300 Enteral Pump from the market due to the possibility that with fluid ingress or other damage, the keypad may not function, and the possibility of motor mount failure.
Frequently asked questions
How many devices does Corpak Medsystems have in the registry?
The registry currently lists 517 devices for Corpak Medsystems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Corpak Medsystems's devices?
Among its 50 most recently registered devices, Corpak Medsystems has devices listed in FDA GUDID (50 devices).
What risk classes do Corpak Medsystems's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Corpak Medsystems's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Corpak Medsystems?
FDA recall records list 5 recalls initiated by Corpak Medsystems, the most recent initiated on 3 Feb 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Corpak Medsystems in the registry?
The most recently registered devices listed for Corpak Medsystems include CORFLO/CORGRIP Tube Retention System Convenience Kit 25-7368PAK, CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 20-9551TRAK2A, CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 42-9361TRAK2 and CORFLO ULTRA NG Feeding Tube 20-7366.