CryoLife recalls SG Pulmonary Hemi-Artery grafts with incorrect labeling of conduit and branch lengths. This labeling error may cause improper use during medical procedures.
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.
CryoLife is recalling a specific type of pulmonary artery graft due to a labeling error that shows the wrong conduit and branch lengths. This could lead to improper use during medical procedures if the graft is not used correctly.
The product labeling incorrectly states the conduit length as 1.0cm and branch length as 4.5cm. This error could lead to improper use during medical procedures if the graft is not used according to the correct specifications.
Patients who received the CryoPatch SG Pulmonary Hemi-Artery graft with model number SGPH00, serial number 10978889, or lot number 144125 are affected. Medical professionals using this graft for procedures are at risk of using it incorrectly.
Check for model number SGPH00, serial number 10978889, or lot number 144125 on the product. The product was sold with an expiration date of 05/16/2022.
Verify the model number, serial number, and lot number on the product to confirm if it is part of the recall.
The recall is due to a labeling error, not a safety hazard. The product is safe to use if the labeling error is corrected.
The official recall notice does not specify a remedy, so no action is required beyond checking the product labeling.
Check for model number SGPH00, serial number 10978889, or lot number 144125 on the product. The product was sold with an expiration date of 05/16/2022.
We’ve drafted a message you can send CryoLife to request your refund or repair — edit it as you like.
Subject: Recall Z-0121-2019 — CryoLife CryoLife Hello, I own a CryoLife that is covered by recall Z-0121-2019 from CryoLife. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
