Drug recall
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula…
FDA recall event 87306 · Class II · Merit Medical Systems, Inc.
Key facts
| Event ID | 87306 |
|---|---|
| Recall numbers | Z-1262-2021, Z-1263-2021 |
| Recalling firm | Merit Medical Systems, Inc. |
| Product type | Devices |
| Products | HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an…, Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended… |
| Initiation date | Jan 19, 2021 |
| Report date | Mar 24, 2021 |
| Termination date | May 17, 2022 |
| City | South Jordan |
| State | UT |
| Country | United States |
| FEI number | 1721504 |
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: