Smiths Medical ASD, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1014-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
Product Description:

Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The 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.

Product Classification:

Class I

Date Initiated: February 6, 2013
Date Posted: April 10, 2013
Recall Number: Z-1014-2013
Event ID: 64543
Reason for Recall:

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

Status: Terminated
Product Quantity: 39
Code Information:

Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, WW3398NC0947.

Distribution Pattern:

USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.

Voluntary or Mandated:

Voluntary: Firm initiated