Drug recall
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2…
FDA recall event 79426 · Class II · Merit Medical Systems, Inc.
Key facts
| Event ID | 79426 |
|---|---|
| Recall numbers | Z-1143-2018, Z-1144-2018, Z-1145-2018 |
| Recalling firm | Merit Medical Systems, Inc. |
| Product type | Devices |
| Products | Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078, Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079, Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits., 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product., 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits. |
| Initiation date | Sep 20, 2017 |
| Report date | Mar 28, 2018 |
| 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: