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 Recall Z-1014-2013 · Posted 2013-03-29
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Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeCCK
Date Initiated2013-02-06
Date Terminated2013-07-12
Product Quantity39
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.
Firm 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 [email protected]. 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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