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Smiths Medical, BCI Remote Alarm Cable (Normally Open &… recallZ-1014-2013 · Smiths Medical ASD, Inc. · initiated Feb 6, 2013

Class I Terminated All recalls posted in March 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1014-2013
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Feb 6, 2013
Posted by the FDA
Mar 29, 2013
Recalling firm
Smiths Medical ASD, Inc.
Quantity
39
Product code
CCK
FDA submissions
K970209
Distribution
USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.

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.

Code information (models, lots, serial numbers)

Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, WW3398NC0947.

Other devices under the same FDA submission

9 devices cleared under K970209 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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