Drug recall
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis…
FDA recall event 69938 · Class II · Arrow International Inc
Key facts
| Event ID | 69938 |
|---|---|
| Recall numbers | Z-1007-2015 |
| Recalling firm | Arrow International Inc |
| Product type | Devices |
| Products | The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit. |
| Initiation date | Feb 4, 2013 |
| Report date | Jan 28, 2015 |
| Termination date | Oct 14, 2016 |
| City | Reading |
| State | PA |
| Country | United States |
| FEI number | 2518433 |
At a glance
- 1–9 Products in this recall
- 1–9 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: