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Terminated

Cruciform Slit Valve

FDA Recall Z-0585-04 · Posted 2004-07-20

Recalling FirmPhoenix Biomedical
Recall StatusTerminated
Product CodeJXG
Date Initiated2004-01-06
Date Terminated2004-03-03
Product Quantity5 units

Reason for Recall

mislabeled - product actually Single Valve

Firm Action

The recalling firm faxed copies of recall letters to the hospitals informing them of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The product was shipped to two hospitals - one in CA and one in AZ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K853363H-H CRUCIFORM-SLIT VALVEHolter-Hausner Intl. · 1985-09-03K790126VALVE, H-H CRUCIFORM SLITHolter-Hausner Intl. · 1979-01-26

Official Source

View FDA Recall →

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

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