Drug recall
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral…
FDA recall event 91529 · Class II · Access Vascular, Inc
Key facts
| Event ID | 91529 |
|---|---|
| Recall numbers | Z-1155-2023 |
| Recalling firm | Access Vascular, Inc |
| Product type | Devices |
| Products | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product Mislabeled on the outer bag and inner kit Tyvek header bag |
| Initiation date | Dec 22, 2022 |
| Report date | Mar 1, 2023 |
| City | Billerica |
| State | MA |
| Country | United States |
| FEI number | 3021570645 |
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: