Reported Feb 11, 2015 · Terminated

Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is…

Cardinal Health

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: Cardinal Health · 1300 Waukegan Rd · Waukegan, IL · 60085-6724

Is this the product you have?

  • Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
Lot codes and dates
  • Material NumberISL6
  • Lot Numbers
    • 1409LS45A-SH
    • 1408LS41A-SH
    • 1406LS22A-SH
    • 1404LS14A-SH
    • 1310LS23A-SH
    • 1310LS21A-SH
    • 1308LS17A-SH
    • 1307LS14A-SH
    • 1303LS04A-SH
    • 1204LS03A-SH
    • 1110LS10A-SH
    • 1111LS11A-SH
    • 1107LS07A-SH
    • 1106LS06A-SH
    • 1104LS04A-SH
    • 1105LS05A-SH
    • 1003020386-SH
    • 912022138-SH
    • 910021815-SH
    • 907021095-SH
Amount recalled
104,432 stylets

Where it was sold

Why it was recalled

A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.

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 Aug 1, 2016 · Data as of Sep 19, 4:49 PM UTC

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