# P030039: Coseal Surgical Sealant

- Pathway: PMA
- Applicant: Baxter Bio Science
- Decided: Dec 12, 2003 after 149 days
- Product code: NBE (Sealant, Polymerizing)
- Device class: 3
- Recalls of this device: 6 (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
- Dec 6, 2023 · Class II · Z-0657-2024: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for
- May 12, 2016 · Class II · Z-1838-2016: Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
- Jul 28, 2011 · Not classified · Z-1614-2012: The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a Coseal st
- Jan 14, 2010 · Not classified · Z-1950-2010: The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the pe
- Jan 14, 2010 · Not classified · Z-1949-2010: The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the pe
- Jan 14, 2010 · Not classified · Z-1948-2010: The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the pe

Source page: https://510kreport.com/device/P030039
Methodology: https://510kreport.com/methodology