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Terminated

CryoPatch SG Pulmonary Hemi-Artery Patch

FDA Recall Z-1219-2019 · Posted None

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeDXZ
Date Initiated2016-11-21
Date Terminated2019-09-24
Product Quantity1

Reason for Recall

The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.

Firm Action

The firm sent the physician a letter on 11/21/2016.

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

Product was shipped to Texas

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091626CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCHCryolife, Inc. · 2009-08-07

Official Source

View FDA Recall →

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

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