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Recall Observatory FDA recall evidence

Device product

OxyMask O2 Adult REF OM-1125-14

Z-2141-2021

May 25, 2021

Class II

Product summary

Firm
Southmedic, Inc.
Event
Event 88103
Status
Ongoing
Classification
Class II
Quantity
160 cases (25 units per case) in U.S.
Official record key
device-enforcement:Z-2141-2021

Official wording

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.

Code information: Model: OM-1125-14 Lot Number: W73887

Distribution pattern: U.S.: IL O.U.S.: N/A

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.