Drug recall
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
FDA recall event 89760 · Class II · Abbott Vascular
Key facts
| Event ID | 89760 |
|---|---|
| Recall numbers | Z-0921-2022, Z-0922-2022, Z-0923-2022, Z-0924-2022, Z-0925-2022 |
| Recalling firm | Abbott Vascular |
| Product type | Devices |
| Products | 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01), 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01), 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01), INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01), Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to an increase in complaint trend for leaks and intermittent/loose connections. |
| Initiation date | Mar 11, 2022 |
| Report date | Apr 20, 2022 |
| City | Temecula |
| State | CA |
| Country | United States |
| FEI number | 2024168 |
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: