Device product
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Z-0234-2026
Product summary
- Event
- Event 97675
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,267,150 syringes
- Official record key
device-enforcement:Z-0234-2026
Official wording
Reason: Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Code information: UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158,
Distribution pattern: Distribution US nationwide and Canada
Derived failure modes
-
Unknown
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.