Drug recall
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
FDA recall event 90913 · Class II · Datascope Corporation
Key facts
| Event ID | 90913 |
|---|---|
| Recall numbers | Z-0131-2023 |
| Recalling firm | Datascope Corporation |
| Product type | Devices |
| Products | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in… |
| Initiation date | Aug 5, 2022 |
| Report date | Nov 2, 2022 |
| City | Fairfield |
| State | NJ |
| Country | United States |
| FEI number | 1000222374 |
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: