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Medline Industries, LP: Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

Medical DevicesSource: FDA (device) · Date: 2025-10-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Reason / hazard
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Classification
Class II
Status
Ongoing
Distribution / sold at
Distribution US nationwide and Canada
Recall initiated
2025-09-11
Code info
UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158,
Product quantity
8,267,150 syringes
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
97675
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