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Terminated

Pulmonary Hemi-Artery SG Used in heart surgery

FDA Recall Z-0809-2014 · Posted 2014-01-23

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeDXZ
Date Initiated2013-11-22
Date Terminated2014-02-20
Product QuantityOne

Reason for Recall

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.

Firm Action

CryoLife sent an Urgent Human Tissue Recall letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CryoLife to arrange for the return of the affected product. If the affected product had been implanted or discarded, customers should provide information regarding the status of the affected product on the attached self-addressed postcard. Customers with questions were instructedto contact the Field Assurance Department at 800-438-8285. For questions regarding this recall call 770-419-3355.

Root Cause

Other

Distribution Pattern

US distribution in CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101866CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCHCryolife, Inc. · 2010-07-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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