Drug recall
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular…
FDA recall event 90647 · Class II · Biosense Webster, Inc.
Key facts
| Event ID | 90647 |
|---|---|
| Recall numbers | Z-1677-2022 |
| Recalling firm | Biosense Webster, Inc. |
| Product type | Devices |
| Products | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices… |
| Initiation date | Jun 29, 2022 |
| Report date | Sep 14, 2022 |
| City | Irwindale |
| State | CA |
| Country | United States |
| FEI number | 3003113629 |
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: