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Recall Observatory FDA recall evidence

Device product

VAPORIZER VICKS 1.5GAL Item Number: 2354942

Z-1935-2021

March 16, 2021

Class II

Product summary

Firm
Cardinal Health Inc.
Event
Event 87787
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1935-2021

Official wording

Reason: Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

Code information: NDC/UPC: 328785101508 All lots numbers shipped from 2/23/201 to 3/10/2021

Distribution pattern: US Nationwide distribution in the states of FL, GA, SC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.