Z-2141-2021 Class II Ongoing
FDA device recall Z-2141-2021 was initiated by Southmedic, Inc. on May 25, 2021 and is designated Class II. Reason for recall: 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 deliv… The recall status is ongoing. Affected quantity: 160 cases (25 units per case) in U.S..
Recall Details
- Product Type
- Devices
- Report Date
- August 4, 2021
- Initiation Date
- May 25, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160 cases (25 units per case) in U.S.
Product Description
OxyMask O2 Adult REF OM-1125-14
Reason for Recall
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.
Distribution Pattern
U.S.: IL O.U.S.: N/A
Code Information
Model: OM-1125-14 Lot Number: W73887