Z-2589-2017 Class II Terminated
FDA device recall Z-2589-2017 was initiated by Smiths Medical ASD Inc. on May 15, 2017 and is designated Class II. 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. The recall status is terminated (terminated April 4, 2018). Affected quantity: 7,035.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 15, 2017
- Termination Date
- April 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,035
Product Description
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.
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.
Distribution Pattern
US Nationwide in the states of PA, TN, NV, CA, MD, AR, CA, VA, OH, MN, NY, VT, NY.
Code Information
Lot#:26X035