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Terminated

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

FDA Recall Z-0121-2019 · Posted None

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeDXZ
Date Initiated2018-09-06
Date Terminated2020-03-03
Product Quantity1 graft

Reason for Recall

The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

Firm Action

A formal recall notice was not sent to the customer involved. The customer complaint was followed up on and the affected graft returned prior to the initiation of the recall for investigation.

Root Cause

Labeling mix-ups

Distribution Pattern

US Nationwide in the state of California.

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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