FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
- Recall number
- Z-1689-2024
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
- Status
- Open, Classified
- Initiated
- 2024-03-15
- Posted
- 2024-04-25
- Terminated
- not on file
- Reason
- Product was distributed in the United States without proper regulatory approval.
- Root cause
- 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
- 165 units
- Distribution
- US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
- Lot, serial or model codes
- UDI/DI 05413765588310, Lot Number DBYSEP046
- 510(k) numbers
- not on file
- PMA numbers
- ["P950034"]
- Product code
- MCN
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28