Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Reported: May 1, 2024 Initiated: March 15, 2024 #Z-1689-2024
Product Description
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Reason for Recall
Product was distributed in the United States without proper regulatory approval.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 165 units
- Distribution
- US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery. Recalled by Baxter Healthcare Corporation. Units affected: 165 units.
Why was this product recalled? ▼
Product was distributed in the United States without proper regulatory approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1689-2024.
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