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Recall Observatory FDA recall evidence

Device product

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

Z-2228-2017

May 10, 2017

Class II

Product summary

Firm
ConvaTec, Inc
Event
Event 77282
Status
Terminated
Classification
Class II
Quantity
816,709
Official record key
device-enforcement:Z-2228-2017

Official wording

Reason: 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.

Code information: Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.