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Pulmonary Hemi-Artery SG Used in heart surgery

FDA Recall #Z-0809-2014 — Class II — November 22, 2013

Recall #Z-0809-2014 Date: November 22, 2013 Classification: Class II Status: Terminated

Product Description

Pulmonary Hemi-Artery SG Used in heart surgery

Reason for Recall

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.

Recalling Firm

CryoLife, Inc. — Kennesaw, GA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

One

Distribution

US distribution in CA.

Code Information

Serial No. 10119759, Model SGPH00

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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