Recalls / —

—#206879

Product

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

FDA product code

MCN — Barrier, Absorbable, Adhesion

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P950034

Affected lot / code info

UDI/DI 05413765588310, Lot Number DBYSEP046

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

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

Timeline

Recall initiated

2024-03-15

Posted by FDA

2024-04-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #206879. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.