Atlas FDA

Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Halle

FDA device recall Z-0388-04 · posted 2004-01-29 · Terminated

Recall details

Recalling firm
Greiner VACUETTE North America
Reason for recall
Product may have a defective connection.
Action taken
Distributors and end users were notified by certified mail or fax on 12/16/2003.
Root cause
Other
Status
Terminated
Product code
FPA
Quantity affected
5 cases (5000 pieces)
Distribution
The product was shipped to medical facilities in IN, NY and TX.
Date initiated
2003-12-16
Date posted
2004-01-29
Date terminated
2004-06-07
Location
Monroe, NC

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Related 510(k) clearances

RecordFirmDate
ECOMED SCALP VEIN SET (K992145)Greiner Meditech, Inc.1999-10-14