CryoValve, Pulmonary Valve & Conduit

FDA device recall Z-0516-04 · posted 2004-02-10 · Terminated

Recall details

Recalling firm

Cryolife Inc

Reason for recall

The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.

Action taken

Consignee was first notified by telephone on 11/10/2003, with a follow up letter sent 12/10/2003. If the tissue had been implanted the consignee was advised to forward that information to CryoLife''s Regulatory Department-Field Assurance. If the tissue had not been implanted the consignee was advised not to implant or further distribute the tissue. They were instructed to remove the tissue from the implantable inventory and to place it into quarantine pending return to CryoLife. A self addressed, stamped postcard was included to affirm receipt of notification and to acknowledge that the tissue had been placed into quarantine.

Root cause

Other

Status

Terminated

Product code

MIE

Quantity affected

1 unit

Distribution

The tissue was issued to one hospital in CA.

Date initiated

2003-11-10

Date posted

2004-02-10

Date terminated

2004-05-06

Location

Kennesaw, GA