FDA recall Z-1689-2024

Baxter Healthcare Corporation · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.

Key facts

Status
Ongoing
Initiation date
2024-03-15
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

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