Baxter Healthcare Corporation Recall 94298
Description: Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Baxter Healthcare Corporation Recall 94298 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1689-2024 |
Event ID | 94298 |
Event Description | Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery |
Product Type | Devices |
Distribution | US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA. |
Quantity | 165 units |
Recall Reason | Product was distributed in the United States without proper regulatory approval. |
Device Classification | 20240501 |
Device Code Info | UDI/DI 05413765588310, Lot Number DBYSEP046 |
Center Classification Date | 20240425 |
Recall Initiation Date | 20240315 |
Recalling Firm | Baxter Healthcare Corporation |
Initial Notification | Letter |
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