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Am2 Pat, Inc.

Country not established

Devices
1
FDA recalls
15

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Am2 Pat, Inc. makes

Am2 Pat, Inc. manufactures heparin lock flush syringes, which are single-use devices designed for flushing and maintaining intravenous catheters to prevent clotting.

These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

  • Heparin Lock Flush Syringe Ref K032417

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

FDA recalls15

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

FDA recall records list 15 recalls initiated by Am2 Pat, Inc., initiated on 2007-12-11. By recorded status: 15 terminated. The reasons filed fall into these groups: sterility or contamination 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.

Showing the 10 most recent of 15 recalls.

  • 2007

    • 11 Dec 2007 Z-0827-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide Submission number: K032417
    • 11 Dec 2007 Z-0828-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0829-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0830-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0831-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0832-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0833-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0834-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0835-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0836-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
Show all 15 recalls

  • 2007

    • 11 Dec 2007 Z-0837-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0838-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0839-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0840-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide
    • 11 Dec 2007 Z-0841-2008 Unclassified (pre-2012) Terminated Lack of assurance of sterility by manufacturer Distribution: Nationwide

Frequently asked questions

How many devices does Am2 Pat, Inc. have in the registry?

The registry currently lists 1 device for Am2 Pat, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Am2 Pat, Inc.'s devices?

Among its 1 most recently registered device, Am2 Pat, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Am2 Pat, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Am2 Pat, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Am2 Pat, Inc.?

FDA recall records list 15 recalls initiated by Am2 Pat, Inc., the most recent initiated on 11 Dec 2007. 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 Am2 Pat, Inc. in the registry?

The most recently registered devices listed for Am2 Pat, Inc. include HEPARIN LOCK FLUSH SYRINGE.

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