Recall Z-1831-2016 ยท FPA Set, Administration, Intravascular
Smiths Medical ASD, Inc.
CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24. The CADD Medication Cassette Reservoirs with Flow Stop are
| Date | Apr 22, 2016 |
| Status | Terminated |
| Reason | Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop. |
| Root cause | Nonconforming Material/Component |
| Action | Smiths Medical sent an "Urgent Medical Device Field Correction Action" letter dated April 20, 2016. The letter was addressed to "Clinicians who oversee the use of the CADD Administration Sets with Flow Stop and Distributors thereof". The letter described the Affected devices, Reason for Field Correction Action, Risk to Health, and Instructions to Customers (Distributors and Clinicians). Requested consignees to complete and return the "Field Corrective Action Confirmation Form". For questions regarding this notification, contact Smiths Medical Customer Service Department at 1-866-831-8399. |
| Quantity | 13,696,830 units |
| Distribution | US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE. OUS: UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PORTUGAL, SAUDI A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040636 | CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET Smiths Medical MD, Inc., May 19, 2004 |