Z-1689-2024Class II

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

Name: Z-1689-2024 Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Creator: Baxter Healthcare Corporation
Published: 2024-03-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-03-15 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery on 2024-03-15. FDA classified it as Class II and gives the reason as "Product was distributed in the United States without proper regulatory approval". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1689-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-15
Posted: 2024-04-25
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Product code: MCN Barrier, Absorbable, Adhesion
Reason for recall: Product was distributed in the United States without proper regulatory approval.
FDA 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 in commerce: 165 units
Distribution: US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
Product codes and lots: UDI/DI 05413765588310, Lot Number DBYSEP046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1689-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1689-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-25

Product code MCN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)