FDA-Device2024-05-01Class II

Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery

Baxter Healthcare Corporation
Hazard

Product was distributed in the United States without proper regulatory approval.

Sold states
US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
Affected count
165 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1689-2024

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