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Terminated

Pulmonary Hemi-Artery SG Used in heart surgery

FDA Recall Z-1561-2011 · Posted 2011-03-04

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeDXZ
Date Initiated2011-02-17
Date Terminated2012-04-24
Product QuantityOne

Reason for Recall

Staphylococcus aureus (not methicillin resistant) identified in companion tissue.

Firm Action

CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355.

Root Cause

Other

Distribution Pattern

Nationwide Distribution including AZ & NV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101866CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCHCryolife, Inc. · 2010-07-23

Official Source

View FDA Recall →

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

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