CADD¿ High Volume Administration Set with FlowStop — Class II medical device recall Z-2589-2017
Terminated recall by Smiths Medical ASD Inc., reported 2017-06-21, distributed nationwide. One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly conta
| Recall number | Z-2589-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2017-05-15 |
| Classified | 2017-06-14 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2018-04-04 |
| Distributed | Nationwide (US) |
| Quantity | 7,035 |
| Lot numbers | 26X035 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2589-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.