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Recall Observatory FDA recall evidence

Device product

Set2Go Ventilation 12 (A), MP07968

Z-1459-2023

April 17, 2023

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 92049
Status
Terminated
Classification
Class I
Quantity
500 units
Official record key
device-enforcement:Z-1459-2023

Official wording

Reason: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Code information: UDI-DI: 04048675544739; All lots.

Distribution pattern: Domestic: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.