Z-0215-2009

VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring...

Name: Z-0215-2009 VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring...
Creator: Greiner Bio-One North America, Inc.
Published: 2008-07-29
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2008-07-29 / Terminated / root cause: labeling and UDI

FDA source

Greiner Bio-One North America, Inc. began a recall of VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged... on 2008-07-29. The reason FDA records is "Labeling Error: Incorrect tube label reads "Z Serum Clot Activator" instead of "LH Lithium Heparin" tube. All other information on the tube label including color coding of tube was correct. Case and rack label...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0215-2009
Status: Terminated
Initiated: 2008-07-29
Posted: 2008-11-07
Terminated: 2009-08-26
Recalling firm: Greiner Bio-One North America, Inc.
Product: VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bio-one NA, Inc., 4238 Capital Drive, Monroe, NC 28110. The Greiner Vacuette blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Labeling Error: Incorrect tube label reads "Z Serum Clot Activator" instead of "LH Lithium Heparin" tube. All other information on the tube label including color coding of tube was correct. Case and rack label information showed the correct information with 2 ml Lithium Heparin.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified by letter on 07/29/2008. Notification letters to distributors instructed them to stop distribution of the product and destroy all affected lots of the product. In addition, notification letters addressed to users instructed them to destroy and discard all products from the item and affected lots. The "Product Disposition Form" must be completed by the consignee and returned to Greiner Bio-One North America, Inc. For questions or additional information, contact Greiner Bio-One North America, Inc. at 704-261-7800.
Quantity in commerce: 33 cases (39,600 pieces)
Distribution: Worldwide including USA (states of AK, AL, AR, CA, CO, DE, GA, ID, IL, IN, KS, LA, MA, MI, MO, MS, NC, ND, NE, NH, NY, OH, OK, OR, PA, RI, SC, SD, TX, VA, VT, WA, and WI) and country of Canada.
Product codes and lots: Lot # B120703.

Product code JKA

K960857Class IIGreiner Vacuette Blood Collection Tube W/lithium Heparin & Gel SeparatorGreiner America, Inc. / cleared 1996-08-30

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)