Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
FDA Recall Z-2272-2018 · Posted None
Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeDXZ
Date Initiated2018-05-14
Date Terminated2019-03-29
Product Quantity1 unit
Reason for Recall
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Firm Action
The firm notified the consignees by letter on 05/14/2018.
Root Cause
Under Investigation by firm
Distribution Pattern
AR, OH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.