Z-0835-2013Class II

VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number...

Name: Z-0835-2013 VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number...
Creator: Greiner Bio-One North America, Inc.
Published: 2013-02-01
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2013-02-01 / Terminated

FDA source

Greiner Bio-One North America, Inc. began a recall of VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used... on 2013-02-01. FDA classified it as Class II and gives the reason as "The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0835-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Posted: 2013-02-15
Terminated: 2013-10-29
Recalling firm: Greiner Bio-One North America, Inc.
Product: VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
FDA root cause: Other
Action: Greiner Bio-One sent a notification letter dated January 31, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to stop distributing the affected product, complete the attached Product Disposition form and fax to GBO at 800-726-0052 or email to [email protected]. GBO will contact customers for the return of the affected product after receiving the attached Product Disposition form. Customers were requested to provide the names of customers who may have received the product. For questions call 800-515-8112.
Quantity in commerce: 192,000 pieces (192 cases)
Distribution: US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
Product codes and lots: Lot No. 12H27

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0835-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0835-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-15

Product code FMI

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)