Ethox International
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Ethox International makes
Ethox International manufactures the SURGI-CUF reusable, RS series, a reusable surgical drape system designed to provide sterile barriers for surgical procedures.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Surgi-Cuf Reusable, Rs Series Ref K061962
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Ethox International, initiated on 2011-03-25. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 25 Mar 2011 Z-0271-2012 Unclassified (pre-2012) Terminated Ethox Tum-E-Vac Gastric Lavage Kit #2075, Lot Number 031123255 was labeled with expiration date symbol and date of 2010/10 on the unit product label. The carton was labeled with a manufacturing date symbol and date of 2010/10. The Ethox Tum-E-Vac Gastric Lavage Kit #2075 does not have an expiration date.
Frequently asked questions
How many devices does Ethox International have in the registry?
The registry currently lists 1 device for Ethox International. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ethox International's devices?
Among its 1 most recently registered device, Ethox International has devices listed in FDA 510(k) (1 device).
What risk classes do Ethox International's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ethox International's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ethox International?
FDA recall records list 1 recall initiated by Ethox International, the most recent initiated on 2011-03-25. 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 Ethox International in the registry?
The most recently registered devices listed for Ethox International include SURGI-CUF REUSABLE, RS SERIES.