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Recall Observatory FDA recall evidence

Device product

Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.

Z-2404-2016

May 11, 2016

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 74664
Status
Terminated
Classification
Class II
Quantity
903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)
Official record key
device-enforcement:Z-2404-2016

Official wording

Reason: There is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup has the correct mL markings for the other gradations, but sequentially, the markings are listed as 2.5 mL, 5 mL, 7.5 mL, and 5 mL.

Code information: Lot Numbers 122211502  122212515

Distribution pattern: Continental U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup has the correct mL markings for the other gradations, but sequentially, the markings are listed as 2.5 mL, 5 mL, 7.5 mL, and 5 mL.