Z-2404-2016 Class II Terminated
FDA device recall Z-2404-2016 was initiated by Medline Industries Inc on May 11, 2016 and is designated Class II. 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… The recall status is terminated (terminated Jun 3, 2019). Affected quantity: 903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 17, 2016
- Initiation Date
- May 11, 2016
- Termination Date
- Jun 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)
Product Description
Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
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.
Distribution Pattern
Continental U.S.
Code Information
Lot Numbers 122211502 122212515
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2404-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026