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Recall Observatory FDA recall evidence

Device product

Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.

Z-2322-2024

May 30, 2024

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 94713
Status
Ongoing
Classification
Class I
Quantity
350 units
Official record key
device-enforcement:Z-2322-2024

Official wording

Reason: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

Code information: Product Code: M07937; Lot numbers: 4210495, 4325617.

Distribution pattern: Nationwide distribution. International distribution to Canada, France, and Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.