Drug recall
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160…
FDA recall event 65317 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 65317 |
|---|---|
| Recall numbers | Z-1672-2013, Z-1673-2013 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract., NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. |
| Initiation date | May 28, 2013 |
| Report date | Jul 17, 2013 |
| Termination date | Jan 23, 2014 |
| City | Marlborough |
| State | MA |
| Country | United States |
| FEI number | 3005099803 |
At a glance
- 1–9 Products in this recall
- None 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: