Reported Oct 17, 2012 · Terminated

3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste…

ICU Medical, Inc.

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: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212

Is this the product you have?

    • 3 PORT "OFF" MANIFOLD w/WASTE BAG
    • SYRINGE and DyePod¿
    • Part Number (Item #) AG8049-NS
    • Lot # 2528655. K914299. Waste system
Lot codes and dates
    • Part Number (Item #) AG8049-NS
    • Lot # 2528655
Amount recalled
60

Where it was sold

  • Nationwide
  • VA

Why it was recalled

ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

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 Feb 19, 2013 · Data as of Sep 19, 4:49 PM UTC

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