Z-1014-2013Class I

Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO &...

Name: Z-1014-2013 Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO &...
Creator: Smiths Medical ASD, Inc.
Published: 2013-02-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-02-06 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide... on 2013-02-06. FDA classified it as Class I and gives the reason as "In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1014-2013
Classification: Class I
Status: Terminated
Initiated: 2013-02-06
Posted: 2013-03-29
Terminated: 2013-07-12
Recalling firm: Abbott Medical
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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 39
Distribution: USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.
Product codes and lots: Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, WW3398NC0947.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1014-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1014-2013	Class I	Terminated	Voluntary: Firm initiated	2013-04-10	2013-03-29

Product code CCK

K970209Class IICapnocheck PlusBci Intl., Inc. / cleared 1997-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)