Recall Z-1692-2015 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Smiths Medical ASD, Inc.
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
| Date | May 29, 2015 (initiated Mar 21, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Consignee 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-medica |
| Quantity | 5 UPDATE 4-20-2015 to include 10 additional devices |
| Distribution | MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030407 | ADVISOR, MODEL 9200 Bci, Inc., Aug 19, 2003 |