Medline Excelsior Medical 0.9% Saline Flush Syringes Recalled Over Concentration Deviation (8.27M)
Medline Recall: Excelsior Medical 0.9% Sodium Chloride Injection, USP, 10 mL fill prefilled saline flush syringes EMZ111240 is being recalled. The notice covers 8,267,150 syringes distributed across the United States and Canada. The risk is a concentration deviation of sodium chloride. Healthcare facilities should stop using the product and follow recall instructions. See the FDA recall page for完整
Quick Facts at a Glance
Recall Date
September 11, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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About This Product
The product is a prefilled saline flush syringe used to rinse IV lines. It is designed for medical settings and used by healthcare professionals.
Why This Is Dangerous
A deviation in sodium chloride concentration could impact saline dosing and patient safety during IV flush procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to identify and remove affected syringes from stock and replace them to ensure correct saline concentration in patient care.
Practical Guidance
How to identify if yours is affected
Identify if you have Excelsior Medical EMZ111240 10 mL prefilled saline flush syringes.
Check UDI codes: Case 10363807000039, Box 363807000032, Each 363807100114.
Review Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158.
Where to find product info
UDI labels on case, box, and individual syringes; Lot numbers printed on packaging.
What timeline to expect
Refunds or replacements typically processed within 4-6 weeks after submission of disposition request.
If the manufacturer is unresponsive
Document all communications with Medline
If Medline is slow, file a complaint with the FDA via MedWatch or the recall page
Consider escalation steps outlined on the recall notice.
How to prevent similar issues
Verify supplier recalls during procurement.
Check UDI and lot numbers before accepting shipments.
Maintain an up-to-date recall log for critical medical supplies.
Documentation advice
Keep recall notices, purchase records, packaging images, and correspondence with Medline for records.
Product Details
Excelsior Medical 0.9% Sodium Chloride Injection, USP — 10 mL fill, EMZ111240. Distribution: US nationwide and Canada. Item Number: EMZ111240. UDI codes and lots listed below.
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