HIGH

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

  1. Identify if you have Excelsior Medical EMZ111240 10 mL prefilled saline flush syringes.
  2. Check UDI codes: Case 10363807000039, Box 363807000032, Each 363807100114.
  3. 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.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Quantity: 8,267,150 syringes recalled
  • Brand: Excelsior Medical
  • Product: 0.9% Sodium Chloride Injection, USP
  • Fill: 10 mL
  • Item Number: EMZ111240
  • Distribution: US nationwide and Canada

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
10363807000039
363807000032
363807100114
25AJA049
25BJA001
+4 more
Affected States
ALL
Report Date
October 29, 2025
Recall Status
ACTIVE

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