Z-0388-04

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

Name: Z-0388-04 Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne...
Creator: Greiner VACUETTE North America
Published: 2003-12-16
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2003-12-16 / Terminated

FDA source

Greiner VACUETTE North America began a recall of Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria on 2003-12-16. The reason FDA records is "Product may have a defective connection". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0388-04
Status: Terminated
Initiated: 2003-12-16
Posted: 2004-01-29
Terminated: 2004-06-07
Recalling firm: Greiner Bio-One North America, Inc.
Product: Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA Greiner & Sohne Gmbh, Bad Haller Str. 32, A-4550 Kremsmunster, Austria.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Product may have a defective connection.
FDA root cause: Other
Action: Distributors and end users were notified by certified mail or fax on 12/16/2003.
Quantity in commerce: 5 cases (5000 pieces)
Distribution: The product was shipped to medical facilities in IN, NY and TX.
Product codes and lots: Item #450271, Lot #12-8461

Product code FPA

K992145Class IIEcomed Scalp Vein SetGreiner Meditech, Inc. / cleared 1999-10-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)