Z-1014-2013 Class I Terminated
FDA device recall Z-1014-2013 was initiated by Smiths Medical ASD, Inc. on Feb 6, 2013 and is designated Class I. 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. The recall status is terminated (terminated Jul 12, 2013). Affected quantity: 39.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2013
- Initiation Date
- Feb 6, 2013
- Termination Date
- Jul 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39
Product Description
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.
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.
Distribution Pattern
USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.
Code Information
Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, WW3398NC0947.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1014-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026