Z-1708-2025 Class II Ongoing
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
- 240 units
Product Description
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
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 10889942529964 (EA) 40889942529965 (CS), Lot Numbers: 23KDB283