Recall Class: Class I
Date Recall Initiated: February 6, 2013
Products: BCI Remote Alarm Cables (NO=Normally Open, NC=Normally Closed), used with 9004 the Capnocheck Capnography (Plus or Sleep) System, Reorder Numbers: WW3398NO & WW3398NC
Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, and WW3398NC0947.
These cables were distributed in Colorado, Illinois, Indiana, Massachusetts, South Carolina, and Wisconsin from October, 2008 through September, 2012.
Use:
The BCI Remote Alarm Cables are 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 Cables and the 9004 Capnocheck Capnography System are intended for use in all critical environments including ventilator applications, patient transport, and anesthesia on patients ranging from pediatric to adult.
Recalling Firm:
Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929
Reason for Recall:
Smiths Medical has become aware that, in rare instances, the BCI Remote Alarm Cables (BCI Cables) are not transferring alarms when used with some remote nurse alarm systems. These products may cause serious adverse health consequences, including death.
Public Contact: Customers may contact the firm’s Medical’s Customer Service Department at 1-800-258-5361.
FDA District: Minneapolis District Office
FDA Comments:
On Feb. 6, 2013, Smiths Medical sent its customers an “Urgent Medical Device Field Safety Notice-Recall” letter by UPS. The letter described the affected product, problem and actions to be taken.
Customers were instructed to:
inspect their inventory
remove all affected devices from use
complete and return the attached “Confirmation Form” by fax at 1-800-237-8033 or by email to BCIRemote.AlarmCable@smiths-medical.com.
The letter stated that a Customer representative will contact customers with instructions for returning the affected products for replacement or credit. For questions, contact Smiths Medical’s Customer Service Department at 1-800-258-5361.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
