Reported Sep 25, 2024 · Ongoing

Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

  • Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Lot codes and dates
    • UDI/DI 40080196031765 (case)
    • 10080196031764 (unit)
  • Lot Numbers96922110001 and 96923100001
Amount recalled
4831 units

Where it was sold

  • Nationwide

Why it was recalled

Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:43 PM UTC

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