Reported Dec 28, 2016 · Terminated

AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to…

Vygon MFG, Inc., dba/ Churchill Medical Systems, 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: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. · 87 Venture Dr · Dover, NH · 03820-5914

Is this the product you have?

  • AMS-651, 120" Microbore extension set with slide clamp
  • Product CodeAMS-651
  • Product UsageAccessory devices used to administer medical fluids
Lot codes and dates
    • 1601064D
    • 1603065D
    • 1605009D
    • 1606038D
    • 1607016D
    • 1607072D
    • 1608067D
    • 1609069D
Amount recalled
31,500

Where it was sold

Why it was recalled

Incorrect priming volume is printed on the device package.

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 Oct 23, 2017 · Data as of Sep 19, 6:46 PM UTC

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