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U.S. Department of Health and Human Services

Class 2 Device Recall BCI Advisor Vital Signs Monitor

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 Class 2 Device Recall BCI Advisor Vital Signs Monitorsee related information
Date Initiated by FirmMarch 21, 2015
Date PostedMay 29, 2015
Recall Status1 Terminated 3 on November 20, 2015
Recall NumberZ-1692-2015
Recall Event ID 70793
510(K)NumberK030407 
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
ProductSmiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Code Information Serial Numbers: 4059587 through 4059591  UPDATED 4-20-2015: additional devices affected have serial numbers: 4059949, 4059950, 4059951, 4059952, 4059953, 4059954, 4059955, 4059957, 4059958 and 4059960
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information ContactCustomer Service Department
651-633-2556
Manufacturer Reason
for Recall		The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionConsignee was sent on 3/20/2015 a Smiths Medical "Urgent Medical Device Recall" letter dated 13 March 2015. The letter was addressed to Supplier Quality. The letter described the issue and the product affected by the recall. Requested consignees to quarantine the affected product and to complete and return the Confirmation Form by Fax to 1-800-237-8033 or by email to recall.response@smiths-medical.com within 10 days of receipt of this letter. Customers shall report any issues with these products to Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcompaints@smiths-medical.com. For questions they can contact Smiths Medical's Customer Service Department at 1-800-258-5361. UPDATE 4-20-2015 Smiths Medical sent an Urgent Medical Device Recall letter via email to the one consignee on April 10, 2015. The letter identified the additional monitors and requested that those devices be quarantined, return the attached confirmation form, and a customer service representative will contact the consignee to arrange for exchange of the affected Advisor monitors for credit or replacement.
Quantity in Commerce5 UPDATE 4-20-2015 to include 10 additional devices
DistributionMN
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CCK
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