medical MODERATE Updated 2017-06-14

ConvaTec, Inc recalls Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tu

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Affected States: CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA
Lot/Code Info: Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall