Z-1689-2024 Class II Ongoing
FDA device recall Z-1689-2024 was initiated by Baxter Healthcare Corporation on Mar 15, 2024 and is designated Class II. Reason for recall: Product was distributed in the United States without proper regulatory approval. The recall status is ongoing. Affected quantity: 165 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- Mar 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165 units
Product Description
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Reason for Recall
Product was distributed in the United States without proper regulatory approval.
Distribution Pattern
US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
Code Information
UDI/DI 05413765588310, Lot Number DBYSEP046
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1689-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026