Z-1714-2025 Class II Ongoing
FDA device recall Z-1714-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on March 19, 2025 and is designated Class II. Reason for recall: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening. The recall status is ongoing. Affected quantity: 159 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2025
- Initiation Date
- March 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159 units
Product Description
Medline procedure kits, labeled as: HAND, REF DYNJ902002J
Reason for Recall
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Code Information
UDI/DI 10195327516079 (EA) 40195327516070 (CS), Lot Numbers: 24ABC106, 23KBN892, 23JBV265