Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Pulmonary Hemi-Artery SG Used in heart surgery Recalled by CryoLife, Inc. Due to Serological testing for the donor was performed with...

Date: November 22, 2013
Company: CryoLife, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CryoLife, Inc. directly.

Affected Products

Pulmonary Hemi-Artery SG Used in heart surgery

Quantity: One

Why Was This Recalled?

Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About CryoLife, Inc.

CryoLife, Inc. has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report