ClearanceBrief
Recall Z-2404-2016 ยท KYW Container, Liquid Medication, Graduated

Medline Industries Inc

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

DateMay 11, 2016
StatusTerminated
ReasonThere 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 causeProcess control
ActionMedline 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.
Quantity903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)
DistributionContinental U.S.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.