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Recall Observatory FDA recall evidence

Device product

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

Z-0163-2022

July 15, 2021

Class III

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 88675
Status
Terminated
Classification
Class III
Quantity
2 units
Official record key
device-enforcement:Z-0163-2022

Official wording

Reason: Two devices were labeled with the same serial number

Code information: SN RF70121

Distribution pattern: UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Two devices were labeled with the same serial number