FDA Device recall Z-2228-2017
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E
- FDA Device
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E by Convatec, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2228-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-10 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Convatec |
| Distribution | CA, CT, FL, GA, IL, MO, NC, NJ, NY, OH, PA, PR, RI, VA |
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.
Identifiers
| code_info | Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2228-2017%22
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