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Supple Peri-Guard

SYNOVIS LIFE TECHNOLOGIES, INC. · Model SPG1016 · UDI-DI 00085412818429

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

Recalls

Date	Firm	Reason
2023-12-06	Baxter Healthcare Corporation	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 produ
2023-12-06	Baxter Healthcare Corporation	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 produ

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.