Home / Recalls / Southmedic, Inc. / Z-2141-2021

Z-2141-2021 Class II Ongoing

Recalled by Southmedic, Inc. — Barrie, N/A

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

Other recalls by Southmedic, Inc.

  • Z-0279-2023 Class II — Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, ST (October 27, 2022)
  • Z-1892-2018 Class II — Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be use (November 6, 2017)
  • Z-1288-2018 Class II — Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks (October 17, 2017)