CryoLife recalls Cryovalve SG Pulmonary Heart Valve (Catalog SGPVVOO) after autopsy reports found morphine in patient urine. This may indicate improper use or contamination.
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
CryoLife is recalling its Cryovalve SG Pulmonary Heart Valve (Catalog Number SGP:GPVVOO) because autopsy reports showed morphine in the patient's urine. This suggests possible improper use or contamination of the device.
The recall is based on autopsy reports finding morphine in the patient's urine. This could indicate that the device was contaminated or used improperly, potentially leading to adverse effects.
Patients who received the Cryovalve SG Pulmonary Heart Valve with Catalog Number SGPVVOO are affected. Those with the specific serial number 10988203 are at higher risk.
Check for the product name 'Cryovalve SG Pulmonary Human Heart Valve' and catalog number SGPVVOO. The specific serial number 10988203 is also listed in the recall.
Look for the catalog number SGPVVOO and serial number 10988203 on the device.
The recall is based on autopsy reports finding morphine in the patient's urine, which may indicate improper use or contamination.
Check the product for the catalog number SGPVVOO and serial number 10988203. If you have these details, contact CryoLife for further instructions.
The recall does not specify a risk of serious injury; the hazard is based on morphine found in urine during autopsy.
We’ve drafted a message you can send CryoLife to request your refund or repair — edit it as you like.
Subject: Recall Z-2271-2018 — CryoLife CryoLife Hello, I own a CryoLife that is covered by recall Z-2271-2018 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.
