Prefilled saline flush syringes recalled over sodium chloride concentration shortfall
Medline is recalling 8,267,150 Excelsior Medical 0.9% Sodium Chloride prefilled flush syringes because a limited quantity may not meet the required concentration of sodium chloride.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: a flush solution that may not meet its stated sodium chloride concentration is administered intravenously, and no injuries are reported.
Plain-English summary
Excelsior Medical 0.9% Sodium Chloride Injection, USP, 10 mL fill, item number EMZ111240, supplied as prefilled saline flush syringes, is being recalled.
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
The recall covers 8,267,150 syringes carrying case UDI 10363807000039, box UDI 363807000032 and each UDI 363807100114, across lots including 25AJA049. Distribution was nationwide in the United States and Canada. The FDA has classified the action as Class II.
The enforcement record describes the concentration problem and reports no injuries. Facilities should identify affected lots and follow Medline's instructions.
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 — IV flush
- Affected units
- 8,267,150
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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