Custom Fluid Management Set — Class II medical device recall Z-0649-2017
Terminated recall by Merit Medical Systems, Inc., reported 2016-11-30, distributed nationwide. Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding
| Recall number | Z-0649-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2016-08-12 |
| Classified | 2016-11-21 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 107,341 devices |
| Model numbers | 701610001, K-08-2192A, K08-02053A, K08-02111A, K08-02385, K08-02385P, K08-02649, K08-02690, K08-02930A, K08-03044, K08T-02829, K09-00807AD, K09-01467AC, K09-01467AD, K09-01732N, K09-02334N, K09-02608A, K09-03491HP, K09-03586AC, K09-03743L, K09-04300Q, K09-04775HP, K09-04916JP, K09-05525A, K09-05648GP and 118 more |
Product
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
Reason for recall
Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
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-0649-2017. 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.