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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Seprafilm Adhesion Barrier

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  Class 2 Device Recall Baxter Seprafilm Adhesion Barrier see related information
Date Initiated by Firm March 15, 2024
Date Posted April 25, 2024
Recall Status1 Open3, Classified
Recall Number Z-1689-2024
Recall Event ID 94298
PMA Number P950034 
Product Classification Barrier, absorbable, adhesion - Product Code MCN
Product Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Code Information UDI/DI 05413765588310, Lot Number DBYSEP046
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Product was distributed in the United States without proper regulatory approval.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 165 units
Distribution US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MCN and Original Applicant = Baxter Healthcare Corporation
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