Recalls / —

—#193727

Product

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

FDA product code

OHY — Pill Crusher/Cutter

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Process change control

Action the firm took

The firm issued a recall notice to consignees on 05/11/2022 via mail. The letter instructs the consignee to check their stock, destroy affected product, and return the response form. On 5/16/2022, the firm sent out an updated recall notice.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

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

Timeline

Recall initiated

2022-05-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #193727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.