VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12"… recallZ-0835-2013 · Greiner Bio-One North America, Inc. · initiated Feb 1, 2013
Class II Terminated All recalls posted in February 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Greiner Bio-One North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0835-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 1, 2013
- Posted by the FDA
- Feb 15, 2013
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 192,000 pieces (192 cases)
- Product code
- FMI
- FDA submissions
- K011786
- Distribution
- US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA
Product description
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.
Code information (models, lots, serial numbers)
Lot No. 12H27
Other devices under the same FDA submission
5 devices cleared under K011786 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vacuette 450082Greiner Bio-One GmbH · Needle, hypodermic, single lumen3 reports
- Vacuette 450096Greiner Bio-One GmbH · Needle, hypodermic, single lumen3 reports
- Vacuette 450161Greiner Bio-One GmbH · Needle, hypodermic, single lumen2 reports
- Vacuette 450086Greiner Bio-One GmbH · Needle, hypodermic, single lumen1 report
- Vacuette 450095Greiner Bio-One GmbH · Needle, hypodermic, single lumen1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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