FDA-Device2017-06-14Class II
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
ConvaTec, Inc
Hazard
Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
Sold states
CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
Affected count
816,709
Manufactured in
7900 Triad Center Dr Ste 400, N/A, Greensboro, NC, United States
Products
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2228-2017Don't want to check this manually?
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