Drug recall
Fluid Management Set. Catalog Number K08-MP5159A
FDA recall event 75367 · Class II · Merit Medical Systems, Inc.
Key facts
| Event ID | 75367 |
|---|---|
| Recall numbers | Z-0631-2017, Z-0632-2017, Z-0633-2017, Z-0634-2017, Z-0635-2017 |
| Recalling firm | Merit Medical Systems, Inc. |
| Product type | Devices |
| Products | Fluid Management Set. Catalog Number K08-MP5159A, Manifold Kit. Catalog Number K09-11867AP, Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G, Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A, Waste Management Kit. Catalog Number K10-04381AP |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier. |
| Initiation date | Sep 23, 2016 |
| Report date | Nov 30, 2016 |
| Termination date | Mar 27, 2017 |
| City | South Jordan |
| State | UT |
| Country | United States |
| FEI number | 1721504 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: