—#148136

Product

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

FDA product code: KYW — Container, Liquid Medication, Graduated
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Lot Numbers 122211502 122212515

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Medline Industries sent a an URGENT RECALL letter dated 5/11/2016 to all affected consignees via certified mail. The URGENT RECALL letter described the reason for the recall and the actions to take.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4485

Distribution

Distribution pattern: Continental U.S.

Timeline

Recall initiated: 2016-05-11
Terminated: 2019-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148136. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.