ConvaTec, Inc: Medical Device Recall in 2017 - (Recall #: Z-2228-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 10, 2017

Date Posted: June 14, 2017

Recall Number: Z-2228-2017

Event ID: 77282

Reason for Recall:

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.

Status: Terminated

Product Quantity: 816,709

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

Voluntary or Mandated:

Voluntary: Firm initiated