Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF… recallZ-1689-2024 · Baxter Healthcare Corporation · initiated Mar 15, 2024
Class II Open, Classified All recalls posted in April 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was distributed in the United States without proper regulatory approval.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1689-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 15, 2024
- Posted by the FDA
- Apr 25, 2024
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 165 units
- Product code
- MCN
- FDA submissions
- P950034
- Distribution
- US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
Product description
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Code information (models, lots, serial numbers)
UDI/DI 05413765588310, Lot Number DBYSEP046
Other devices under the same FDA submission
1 device cleared under P950034 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SEPRAFILM 430102Baxter Healthcare Corporation · Barrier, absorbable, adhesion1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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