CADD — Class II medical device recall Z-0060-2018
Terminated recall by Smiths Medical ASD Inc., reported 2017-11-08, distributed nationwide. Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been ma
| Recall number | Z-0060-2018 |
|---|---|
| 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 | 2017-09-25 |
| Classified | 2017-11-01 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2020-08-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BM, CA, CH, CL, CN, CO, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IT, JP, LB, LU, MY, NL, NO, NZ, PH, PT, SA, SE, SG, ZA |
| Quantity | 2,827,352 units |
| Model numbers | 21-7001-24 |
Product
CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).
Reason for recall
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
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-0060-2018. 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.