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U.S. Department of Health and Human Services

Class 1 Device Recall BCI Remote Alarm Cable Normally Open /Normally Closed

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  Class 1 Device Recall BCI Remote Alarm Cable Normally Open /Normally Closed see related information
Date Initiated by Firm February 06, 2013
Date Posted March 29, 2013
Recall Status1 Terminated 3 on July 12, 2013
Recall Number Z-1014-2013
Recall Event ID 64543
510(K)Number K970209  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
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.
Code Information Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, WW3398NC0947.
Recalling Firm/
Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action 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.
Quantity in Commerce 39
Distribution USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CCK and Original Applicant = BCI INTL., INC.