CryoValve Allograft, Heart valve

FDA device recall Z-0672-03 · posted 2003-03-21 · Terminated

Recall details

Recalling firm

Cryolife Inc

Reason for recall

Microorganisms were detected in distributed allografts.

Action taken

CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue. Health Canada was notified of all voluntary actions on the allografts distributed in Canada.

Root cause

Other

Status

Terminated

Product code

MIE

Quantity affected

2 units

Distribution

The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.

Date initiated

2003-02-04

Date posted

2003-03-21

Date terminated

2003-07-16

Location

Kennesaw, GA