Reported Oct 24, 2018 · Terminated

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

CryoLife, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CryoLife, Inc. · 1655 Roberts Blvd Nw · Kennesaw, GA · 30144-3632

Is this the product you have?

  • CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Lot codes and dates
    • Model Number SGPH00
    • Serial Number 10978889
    • Lot Number 144125
    • Expiration Date 05/16/2022
Amount recalled
1 graft

Where it was sold

  • Nationwide
  • CA

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 3, 2020 · Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.