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Baxter Healthcare Corporation Recall 94298

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

Baxter Healthcare Corporation Recall 94298 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1689-2024
Event ID94298
Event DescriptionBaxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Product TypeDevices
DistributionUS Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
Quantity165 units
Recall ReasonProduct was distributed in the United States without proper regulatory approval.
Device Classification20240501
Device Code InfoUDI/DI 05413765588310, Lot Number DBYSEP046
Center Classification Date20240425
Recall Initiation Date20240315
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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