Drug recall
The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon…
FDA recall event 84134 · Class II · Nucryo Vascular Inc.
Key facts
| Event ID | 84134 |
|---|---|
| Recall numbers | Z-0507-2020 |
| Recalling firm | Nucryo Vascular Inc. |
| Product type | Devices |
| Products | The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels. |
| Initiation date | Oct 11, 2019 |
| Report date | Nov 27, 2019 |
| Termination date | May 3, 2021 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 3011393614 |
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: