ConvaTec, Inc recalls Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;

Recall date

May 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2228-2017

FDA classification

Class II

Brand / firm

ConvaTec, Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;