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Open, Classified

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

FDA Recall Z-1689-2024 · Posted 2024-04-25

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeMCN
Date Initiated2024-03-15
Product Quantity165 units

Reason for Recall

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

Firm Action

Baxter issued an Urgent Medical Device Recall notice to its consignee on 03/15/2024 via USPS, first class mail. The notice explained the issue, hazard, and requested the following: Immediately locate, isolate, and cease all use of the affected lot number of the product. . Baxter Healthcare will contact impacted customers to arrange for replacement product, return, and credit. If additional support is needed, customers can contact Baxter Healthcare Center for Service.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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