Pulmonary Hemi-Artery SG Used in heart surgery

Recall Insight

This FDA Devices action (record #Z-0809-2014) was formally reported on January 29, 2014, with the manufacturer initiating the action on November 22, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. CryoLife, Inc. is listed as the recalling firm, operating out of Kennesaw, GA. Federal records indicate One units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US distribution in CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.