CryoValve Allograft, heart valve

FDA device recall Z-0673-03 · posted 2003-03-21 · Terminated

Recall details

Recalling firm

Cryolife Inc

Reason for recall

Microorganisms were detected in distributed donor tissue.

Action taken

Medical facilities were contacted by CryoLife Technical Representatives via letter on/about 2/20/2003 to alert the facility of the removal and to determine the disposition of the allografts. Firms were advised, if the tissue has not been implanted, not to implant or distribute the tissue and to place it into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department-Field Assurance, and a representative would issue a Return Materials Authorization number and will provide specific instructions for returning the tissue. There is a stamped, self addressed postcard attached to affirm receipt of the notification.

Root cause

Other

Status

Terminated

Product code

MIE

Quantity affected

There were six (6) individual heart valve allografts.

Distribution

Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or government accounts.

Date initiated

2003-02-18

Date posted

2003-03-21

Date terminated

2003-07-21

Location

Kennesaw, GA