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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Industries Inc.

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  Class 2 Device Recall Medline Industries Inc. see related information
Date Initiated by Firm May 11, 2016
Create Date August 11, 2016
Recall Status1 Terminated 3 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/
Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4485
For Additional Information Contact Kathy Dunne
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 2
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.