SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall:
SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

Product Codes/Lot Numbers:

UDI-DI 00363807103016 (ea) 10363807103013 (box) 20363807103010 (case) Lots 3144609 3144857 3144886 3144967 3145090 3145186

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2199-2025

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