Recall Z-1014-2013— Smiths Medical ASD, Inc.

Name: FDA recall Z-1014-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-06

Class I · Terminated

Class I FDA medical device recall by Smiths Medical ASD, Inc., initiated 2013-02-06, terminated 2013-07-12. It names one FDA 510(k) clearance: K970209. Product: 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.. Reason: In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when used with some remote nurse alarm systems..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class I
Status: Terminated
Initiated: 2013-02-06
Terminated: 2013-07-12
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K970209 — CAPNOCHECK PLUSBci Intl., Inc.·cleared 1997-04-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.