Reported Nov 13, 2013 · Terminated

Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as…

Baxter Healthcare Corp.

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: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
Lot codes and dates
    • 10043
    • 10044
Amount recalled
628,992 units

Where it was sold

  • Nationwide

Why it was recalled

The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.

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

Notice updated Jun 5, 2015 · Data as of Sep 19, 4:48 PM UTC

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