Device product
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
Z-1708-2025
Product summary
- Event
- Event 96630
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 240 units
- Official record key
device-enforcement:Z-1708-2025
Official wording
Reason: 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.
Code information: UDI/DI 10889942529964 (EA) 40889942529965 (CS), Lot Numbers: 23KDB283
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Derived failure modes
-
Unknown
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.