# P950034: Seprafilm (TM) (Hal-F (TM)) Bioresorbable Membrane

- Pathway: PMA
- Applicant: Baxter Healthcare Corporation
- Decided: Aug 12, 1996 after 290 days
- Product code: MCN (Barrier, Absorbable, Adhesion)
- Device class: 3
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 15, 2024 · Class II · Z-1689-2024: Product was distributed in the United States without proper regulatory approval.
- Jun 13, 2012 · Class II · Z-1856-2012: Sterility of product may be compromised due to packaging defect
- Jun 13, 2012 · Class II · Z-1855-2012: Sterility of product may be compromised due to packaging defect
- Apr 10, 2008 · Not classified · Z-1648-2008: Sterility may be compromised
- Apr 10, 2008 · Not classified · Z-1647-2008: Sterility may be compromised

Source page: https://510kreport.com/device/P950034
Methodology: https://510kreport.com/methodology