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ConvaTec, Inc recalls Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Recalled June 14, 2017 · FDA recall Z-2228-2017 · ConvaTec
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. · FDA Class II
Units
816,709
Sold at
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
Description
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.
Product
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Manufacturer(s)
ConvaTec, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →