Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use
FDA device recall Z-1014-2013 · posted 2013-03-29 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- 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.
- Action taken
- 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 questions contact Smiths Medical's Customer Service Department at 10-800-258-5361.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 39
- Distribution
- USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.
- Date initiated
- 2013-02-06
- Date posted
- 2013-03-29
- Date terminated
- 2013-07-12
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAPNOCHECK PLUS (K970209) | Bci Intl., Inc. | 1997-04-18 |