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Recall Observatory FDA recall evidence

Device product

Medline Pill Splitters; 1 each/box; 144 boxes/carton

Z-1287-2022

May 11, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 90196
Status
Ongoing
Classification
Class II
Quantity
840,087 each
Official record key
device-enforcement:Z-1287-2022

Official wording

Reason: Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.

Code information: Model Number: NON135000; UDI/DI:8019673489; Lot Numbers: 50920060001, 50920080001, 50920110001, 50921030001, 50921040001, 50921050001, 50921060001, 50921080001, 50921090001, 50921100001, 50921110001, 50921120001, 50922020001

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Panama, and Hongkong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.