Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
This recall has been terminated (originally issued May 24, 2017).
- Company
- Convatec, Inc
- Recall Initiated
- May 10, 2017
- Posted
- May 24, 2017
- Terminated
- August 27, 2021
- Recall Number
- Z-2228-2017
- Quantity
- 816,709
- Firm Location
- Greensboro, NC
- Official Source
- View on FDA website ↗
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.
Distribution
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
Lot / Code Info
Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530
Root Cause
Process control
Action Taken
Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.