Drug recall
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC…
FDA recall event 87329 · Class I · Cordis Corporation
Key facts
| Event ID | 87329 |
|---|---|
| Recall numbers | Z-1257-2021 |
| Recalling firm | Cordis Corporation |
| Product type | Devices |
| Products | PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC… |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Distal tip may become separated from the lumen wire in specific lots. |
| Initiation date | Feb 11, 2021 |
| Report date | Mar 24, 2021 |
| City | Miami Lakes |
| State | FL |
| Country | United States |
| FEI number | 1016427 |
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: