Device product
Medline procedure kits, labeled as: HAND, REF DYNJ902002J
Z-1714-2025
Product summary
- Event
- Event 96630
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 159 units
- Official record key
device-enforcement:Z-1714-2025
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 10195327516079 (EA) 40195327516070 (CS), Lot Numbers: 24ABC106, 23KBN892, 23JBV265
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.