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Terminated

Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.

FDA Recall Z-0388-04 · Posted 2004-01-29

Recall StatusTerminated
Product CodeFPA
Date Initiated2003-12-16
Date Terminated2004-06-07
Product Quantity5 cases (5000 pieces)

Reason for Recall

Product may have a defective connection.

Firm Action

Distributors and end users were notified by certified mail or fax on 12/16/2003.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities in IN, NY and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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