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Terminated

Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

FDA Recall Z-2271-2018 · Posted None

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeOHA
Date Initiated2018-05-14
Date Terminated2019-03-29
Product Quantity1 unit

Reason for Recall

Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.

Firm Action

The firm notified the consignees by letter on 05/14/2018.

Root Cause

Under Investigation by firm

Distribution Pattern

AR, OH

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092021CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)Cryolife, Inc. · 2010-05-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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