Smiths Medical — Class I medical device recall Z-1014-2013
Terminated recall by Smiths Medical ASD, Inc., reported 2013-04-10, distributed nationwide. In rare instances, the BCI¿ Remote Alarm Cables (BCI¿ Cable) are not transferring alarms when used with some r
| Recall number | Z-1014-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Saint Paul, MN, United States |
| Recall initiated | 2013-02-06 |
| Classified | 2013-03-29 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2013-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 39 |
| Lot numbers | WW3398NC0822, WW3398NC0847, WW3398NC0947, WW3398NO0820, WW3398NO0847, WW3398NO0948 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1014-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.