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.
FDA Recall Z-2589-2017 · Posted None
Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2017-05-15
Date Terminated2018-04-04
Product Quantity7,035
Reason for Recall
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.
Firm 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 [email protected] 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: [email protected].
Root Cause
Process control
Distribution Pattern
US Nationwide in the states of PA, TN, NV, CA, MD, AR, CA, VA, OH, MN, NY, VT, NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.