Recall Z-2141-2021 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Southmedic, Inc.
OxyMask O2 Adult REF OM-1125-14
| Date | May 25, 2021 |
| Status | Open, Classified |
| Reason | Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient. |
| Root cause | Nonconforming Material/Component |
| Action | On 05/25/2021, the firm sent an "Urgent Medical Device Recall" Notice Letter via email with a follow-up telephone conversation on 06/03/2021 to inform customer that the Recalling Firm has become aware of the potential for disconnection of the oxygen tubing at the mask's elbow. This disconnection may result in a loss of device function leading to a lack of oxygen delivery to the patient. Customers are instructed to take the following actions: 1. Review your inventory and confirm whether you are still in possession of the impacted product. 2. Complete the Confirmation Form provided and fax the |
| Quantity | 160 cases (25 units per case) in U.S. |
| Distribution | U.S.: IL O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.