Drug recall
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
FDA recall event 94298 · Class II · Baxter Healthcare Corporation
Key facts
| Event ID | 94298 |
|---|---|
| Recall numbers | Z-1689-2024 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Devices |
| Products | Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product was distributed in the United States without proper regulatory approval. |
| Initiation date | Mar 15, 2024 |
| Report date | May 1, 2024 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
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: