Recall Z-2589-2017 ยท FPA Set, Administration, Intravascular
Smiths Medical ASD Inc.
CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV bag.
| Date | May 15, 2017 |
| Status | Terminated |
| Reason | One lot of CADD High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24. |
| Root cause | Process control |
| Action | Consignees were sent on 5/15/2017 a Smiths Medical "Urgent Medical device Recall Notice" dated May 15, 2017. The letter described the Affected Devices, Reason for Recall, Risk to Health, & Instructions to Customers. Advised consignees to complete and send the Urgent Medical Device Recall Response Form to smithsmedical7903@stericycle.com within 10 calendar days of receipt of this Notice.If you have distributed affected devices to your customers, immediately notify your customers of this Recall and retrieve all affected devices. For questions contact Stericycle via email at: smithsmedical7903@ |
| Quantity | 7,035 |
| Distribution | US Nationwide in the states of PA, TN, NV, CA, MD, AR, CA, VA, OH, MN, NY, VT, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031361 | CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP Deltec, Inc., May 23, 2003 |