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Greiner Vacuette North America, Inc.

United StatesFDA applicant, unverified

Devices
5
FDA recalls
4

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Greiner Vacuette North America, Inc. makes

Greiner Vacuette North America, Inc. manufactures blood collection tubes, including EDTA K2 and EDTA K2 gel variants, as well as quick-release tube holders and blood collection sets with safety features. Their products are designed for venipuncture and serum separation, often incorporating additives like PPACK for anticoagulation or stabilization.

These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company’s portfolio is registered in the United States, where its products are intended for clinical and diagnostic use.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

  • Vacuette Edta K2 Tubes Ref K014104

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vacuette Speedy Quick-Release Holder Ref K003812

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vacuette Edta K2 Gel Tubes Ref K012043

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vacuette With Ppack Ref K002777

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vacuette Safety Blood Collection Set Ref K011786

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 4 recalls initiated by Greiner Vacuette North America, Inc., the earliest on 2003-03-10 and the most recent on 2005-07-28. By recorded status: 4 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2005

    • 28 Jul 2005 Z-0086-06 Unclassified (pre-2012) Terminated Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution. Distribution: Nationwide, Chile, Costa Rica, Ecuador, El Salvador, Nicaragua and Uruguay. Submission number: K960858

  • 2004

    • 27 Jul 2004 Z-1331-04 Unclassified (pre-2012) Terminated Coagulation tubes may not have received the proper fill of citrate solution. Distribution: Nationwide Submission number: K971221

  • 2003

    • 16 Dec 2003 Z-0388-04 Unclassified (pre-2012) Terminated Product may have a defective connection. Distribution: The product was shipped to medical facilities in IN, NY and TX. Submission number: K992145
    • 10 Mar 2003 Z-0797-03 Unclassified (pre-2012) Terminated The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter. Distribution: Product was distributed to medical facilities Nationwide. Submission number: K011786

Frequently asked questions

How many devices does Greiner Vacuette North America, Inc. have in the registry?

The registry currently lists 5 devices for Greiner Vacuette North America, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Greiner Vacuette North America, Inc.'s devices?

Among its 5 most recently registered devices, Greiner Vacuette North America, Inc. has devices listed in FDA 510(k) (5 devices).

What risk classes do Greiner Vacuette North America, Inc.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Greiner Vacuette North America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Greiner Vacuette North America, Inc.?

FDA recall records list 4 recalls initiated by Greiner Vacuette North America, Inc., the most recent initiated on 28 Jul 2005. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Greiner Vacuette North America, Inc. in the registry?

The most recently registered devices listed for Greiner Vacuette North America, Inc. include VACUETTE EDTA K2 TUBES, VACUETTE SPEEDY QUICK-RELEASE HOLDER, VACUETTE EDTA K2 GEL TUBES and VACUETTE WITH PPACK.

Generated automatically from registry data and not verified by a human reviewer.