CADD Administration Sets with Flow Stop — Class II medical device recall Z-1831-2016
Terminated recall by Smiths Medical ASD, Inc., reported 2016-06-08, distributed in DC, PR. Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow
| Recall number | Z-1831-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Saint Paul, MN, United States |
| Recall initiated | 2016-04-22 |
| Classified | 2016-05-27 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-12-13 |
| Distributed | DC, PR |
| Countries outside the US | AE, AT, BE, CA, CN, DE, DK, ES, FI, FR, GB, HK, IE, IN, IT, JP, LU, NZ, PA, PT, SA, SE, SG, TW, ZA |
| Quantity | 13,696,830 units |
Product
CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24. The CADD Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump. The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.
Reason for recall
Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
Machine access
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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.