Recall Z-2228-2017— ConvaTec, Inc
Class II · Terminated
Class II FDA medical device recall by ConvaTec, Inc, initiated 2017-05-10, terminated 2021-08-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;. 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..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-10
- Terminated
- 2021-08-27
- Firm location
- Greensboro, NC, United States
Product description
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.