—#116450

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.

FDA product code: CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K970209
Affected lot / code info: Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, WW3398NC0947.

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Smiths Medical sent an "Urgent Medical Device Field Safety Notice-Recall" letter dated February 96, 2013 via UPS to all affected customers. The letter described the affected product, problem and actions to be taken. Customers were instructed to inspect their inventory and remove all affected devices from use, complete and return the attached "Confirmation Form", by fax to 1-800-237-8033 or email to BCIRemote.AlarmCable@smiths-medical.com. The letter stated that a Customer representative will contact customers with instructions for returning affected products for replacement or credit. For questions contact Smiths Medical's Customer Service Department at 10-800-258-5361.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929

Distribution

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

Timeline

Recall initiated: 2013-02-06
Posted by FDA: 2013-03-29
Terminated: 2013-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116450. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.