FDAClass IIJune 27, 2018

Cryopatch SG Pulmonary Human Cardiac Branch recall

Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020

Why was Cryopatch SG Pulmonary Human Cardiac Branch recalled?

Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Number 10988328

Product
Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
Recalling firm
CryoLife, Inc.
Quantity
1 unit
Distribution
AR, OH
Recall date
June 27, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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