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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 Barriersee related information
Date Initiated by FirmMarch 15, 2024
Date PostedApril 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1689-2024
Recall Event ID 94298
PMA NumberP950034 
Product Classification Barrier, absorbable, adhesion - Product Code MCN
ProductBaxter 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 ContactCenter 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
ActionBaxter 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 Commerce165 units
DistributionUS Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MCN
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