Reported Apr 10, 2013 · Terminated

Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For…

Smiths Medical ASD, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Smiths Medical ASD, Inc. · 1265 Grey Fox Rd · Saint Paul, MN · 55112-6929

Is this the product you have?

  • Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed)
  • Reorder NumbersWW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment
  • Product UsageThe BCI¿ Remote Alarm Cable is designed for use with the 9004 Capnocheck¿ Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck¿ Capnography system to a remote alarm system. The BCI¿ Remote Alarm Cable and the 9004 Capnocheck¿ Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia
Lot codes and dates
  • Lot Numbers
    • WW3398NO0820
    • WW3398NO0847
    • WW3398NO0948
    • WW3398NC0822
    • WW3398NC0847
    • WW3398NC0947
Amount recalled
39

Where it was sold

Why it was recalled

Stop using this product now

In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when used with some remote nurse alarm systems.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 12, 2013 · Data as of Sep 19, 5:19 PM UTC

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