Z-0797-03

Vacuette, Safety Blood Collection Set with Luer Adapter

Name: Z-0797-03 Vacuette, Safety Blood Collection Set with Luer Adapter
Creator: Greiner VACUETTE North America
Published: 2003-03-10
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2003-03-10 / Terminated

FDA source

Greiner VACUETTE North America began a recall of Vacuette, Safety Blood Collection Set with Luer Adapter on 2003-03-10. The reason FDA records is "The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0797-03
Status: Terminated
Initiated: 2003-03-10
Posted: 2003-05-09
Terminated: 2003-08-07
Recalling firm: Greiner Bio-One North America, Inc.
Product: Vacuette, Safety Blood Collection Set with Luer Adapter
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
FDA root cause: Other
Action: Consignees were notified via certified letter on/about 3/6/2003 and were advised to stop distributing the product immediately and to discard any remaining product in stock.
Quantity in commerce: 139000 units
Distribution: Product was distributed to medical facilities Nationwide.
Product codes and lots: Item no. 450096, Lot #''s 02I09C, 02I11C and 02I20C

Product code JKA

K011786Class IIVacuette Safety Blood Collection SetGreiner Vacuette North America, Inc. / cleared 2001-07-12

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)