Class 2 Device Recall Medline Industries Inc.

• Date Initiated by Firm: May 11, 2016
• Create Date: August 11, 2016
• Recall Status: Terminated on June 03, 2019
• Recall Number: Z-2404-2016
• Recall Event ID: 74664
• Product Classification: Container, liquid medication, graduated - Product Code KYW
• Product: Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
• Code Information: Lot Numbers 122211502  122212515
• Recalling Firm/ Manufacturer: Medline Industries Inc; 1 Medline Pl; Mundelein IL 60060-4485
• For Additional Information Contact: Kathy Dunne; 847-949-5500
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)
• Distribution: Continental U.S.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.