Device product
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.
Z-2589-2017
Product summary
- Event
- Event 77284
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,035
- Official record key
device-enforcement:Z-2589-2017
Official wording
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.
Code information: Lot#:26X035
Distribution pattern: US Nationwide in the states of PA, TN, NV, CA, MD, AR, CA, VA, OH, MN, NY, VT, NY.
Derived failure modes
-
Unknown
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.