CADD Administration Set — Class I medical device recall Z-0965-2023
Ongoing recall by Smiths Medical ASD Inc., reported 2023-02-08, distributed nationwide. There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery
| Recall number | Z-0965-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2022-12-09 |
| Classified | 2023-01-30 |
| Reported by FDA | 2023-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 214,668 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 30610586044001, 30610586044018, 30610586044742, 35019517184246 |
| Lot numbers | 4072200, 4076410, 4084914, 4092506 |
| Model numbers | 21-7600-24, 21-7600-24JP, 21-7609-24, 21-7609-24JP, 21-7624-24, 21-7624-24JP, 21-7649-24, 21-7649-24JP |
Product
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
Reason for recall
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
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-0965-2023. 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.