Recall Z-1014-2013 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Smiths Medical ASD, Inc.
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
| Date | Mar 29, 2013 (initiated Feb 6, 2013) |
| Status | Terminated |
| Reason | In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems. |
| Root cause | 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 |
| Quantity | 39 |
| Distribution | USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970209 | CAPNOCHECK PLUS Bci Intl., Inc., Apr 18, 1997 |