Arcadia Medical Corporation
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Arcadia Medical Corporation makes
Arcadia Medical Corporation manufactures silicone reinforced endotracheal tubes and tracheostomy tubes, including silicone foam-cuffed and cuffless designs for neonatal and pediatric patients.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal And Pediatric Tracheostomy Tubes Ref K031553
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Arcadia Medical Corporation, the earliest on 2011-05-08 and the most recent on 2012-04-18. By recorded status: 2 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 18 Apr 2012 Z-1628-2012 Not yet classified Terminated A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.
2011
- 8 May 2011 Z-2657-2011 Unclassified (pre-2012) Terminated The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.
Full distribution text
- 8 May 2011 Z-2657-2011 Unclassified (pre-2012) Terminated The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates the user's ability to suction secretions through this suction port, necessitating that the user revert to standard of care methods for suctioning secretions from around the cuffed trach tube shaft.
Frequently asked questions
How many devices does Arcadia Medical Corporation have in the registry?
The registry currently lists 2 devices for Arcadia Medical Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arcadia Medical Corporation's devices?
Among its 2 most recently registered devices, Arcadia Medical Corporation has devices listed in FDA 510(k) (2 devices).
What risk classes do Arcadia Medical Corporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Arcadia Medical Corporation's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Arcadia Medical Corporation?
FDA recall records list 2 recalls initiated by Arcadia Medical Corporation, the most recent initiated on 18 Apr 2012. 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 Arcadia Medical Corporation in the registry?
The most recently registered devices listed for Arcadia Medical Corporation include ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES and SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES.