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Terminated

CryoValve, Pulmonary Valve & Conduit

FDA Recall Z-1297-03 · Posted 2003-10-15

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeNJK
Date Initiated2003-09-10
Date Terminated2004-05-06
Product Quantity1 unit

Reason for Recall

Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.

Firm Action

Consignees were notified by letter on 09/10/2003 and 09/12/2003.

Root Cause

Other

Distribution Pattern

The tissues were distributed to one hospital in CA and one physician in MN.

Official Source

View FDA Recall →

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

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