[pending] Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefill
Pending LLM rewrite. Source: FDA_DEVICE Z-0234-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
The recalled product
- Product
- Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- UDI (Case): 10363807000039
- UDI (Box): 363807000032
- UDI (Each): 363807100114
- Lot Numbers: 25AJA049
- 25BJA001
- 25BJA032
- 25CJA053
- 25CJA105
- 25CJA158
Distribution
Distributed nationwide across the United States.
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