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Recall Observatory FDA recall evidence

Device product

Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.

Z-1954-2018

April 26, 2018

Class II

Product summary

Firm
Draeger Medical, Inc.
Event
Event 80027
Status
Terminated
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-1954-2018

Official wording

Reason: The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.

Code information: Serial nos. ASKM-0065 ASKM-0066 ASKM-0106 ASKM-0134 ASKM-0137 ASKM-0150 ASKM-0151 ASKN-0009

Distribution pattern: Distributed to the states of CT, IL, MN, NV, SD, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.