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Recall Observatory FDA recall evidence

Device product

Pulmonary Hemi-Artery SG Used in heart surgery

Z-0809-2014

November 22, 2013

Class II

Product summary

Firm
CryoLife, Inc.
Event
Event 67182
Status
Terminated
Classification
Class II
Quantity
One
Official record key
device-enforcement:Z-0809-2014

Official wording

Reason: Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.

Code information: Serial No. 10119759, Model SGPH00

Distribution pattern: US distribution in CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.