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MEDEX

France FR-MF-000000414 Last updated 23 Oct 2026 Part of Medex, Inc.

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Devices
38
Registries
EUDAMEDFDA
FDA recalls
11

Catalogue38

FDA recalls11

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

There are 11 recall records for Medex, with the earliest initiated on 2003-06-09 and the most recent on 2005-11-18. All records are listed with a status of terminated. The reasons given include cracking of sampling port bodies that may allow dislodgement, inadequate warning labels regarding use with ECMO procedures, and issues related to latex content in products labeled as 'Latex Free', including natural rubber or rubber by-products in non-rebreathing masks and watertraps not being appropriately labeled, and potential latex presence in components despite 'Latex Free' labeling.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 11 recalls.

  • 2005

    • 18 Nov 2005 Z-0811-06 Unclassified (pre-2012) Terminated The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex.
    • 18 Nov 2005 Z-0812-06 Unclassified (pre-2012) Terminated The product is labeled as 'Latex Free' , however,one of the components of the finished product may contain latex.

  • 2004

    • 20 Oct 2004 Z-0198-05 Unclassified (pre-2012) Terminated Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body.
    • 12 Jul 2004 Z-1122-04 Unclassified (pre-2012) Terminated The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
    • 12 Jul 2004 Z-1123-04 Unclassified (pre-2012) Terminated The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
    • 12 Jul 2004 Z-1124-04 Unclassified (pre-2012) Terminated The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
    • 12 Jul 2004 Z-1125-04 Unclassified (pre-2012) Terminated The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
    • 12 Jul 2004 Z-1126-04 Unclassified (pre-2012) Terminated The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
    • 12 Jul 2004 Z-1127-04 Unclassified (pre-2012) Terminated The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
    • 16 Feb 2004 Z-0813-04 Unclassified (pre-2012) Terminated Inadequate warning label: Medex has determined that it is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side.
Show all 11 recalls

  • 2003

    • 9 Jun 2003 Z-1060-03 Unclassified (pre-2012) Terminated Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.

What MEDEX makes

MEDEX manufactures medical devices including Monoflow D 2 Vial, ManyFlow S Vial, Monoflow, Manyfill 24 S Scanbag, Contrast&Care+, Manyfill D Vial, Manyfill 24 S Vial, Qitexio, Qitexio 3 ML Luer Lock Syringe, Qitexio 20 ML Luer Lock Syringe, Enema Bags, and Enema bags. These products are primarily fluid handling and delivery systems such as syringes, vials, scan bags, and enema bags used in clinical settings.

The devices are classified as Class I and Class IIa under the EU regulatory framework and are listed in the Eudamed database. The company is based in France.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does MEDEX manufacture?

MEDEX manufactures medical devices such as Monoflow D 2 Vial, ManyFlow S Vial, Monoflow, Manyfill 24 S Scanbag, Contrast&Care+, Manyfill D Vial, Manyfill 24 S Vial, Qitexio, Qitexio 3 ML Luer Lock Syringe, Qitexio 20 ML Luer Lock Syringe, Enema Bags, and Enema bags. These are fluid handling and delivery systems used in clinical settings, including syringes, vials, scan bags, and enema bags.

Where is MEDEX based?

MEDEX is based in France, as indicated by the country code FR in the provided data. This establishes the company's location within the European regulatory jurisdiction.

In which regulatory registry are MEDEX's devices listed?

MEDEX's devices are listed in the Eudamed database, which is the official European database for medical devices under the EU Medical Device Regulation (MDR). This listing allows for traceability and regulatory oversight of their products in the EU market.

How are MEDEX's devices classified under EU regulations?

MEDEX's devices are classified as Class I and Class IIa under the EU regulatory framework. This classification reflects the level of risk associated with the devices, with Class I being low risk and Class IIa being medium risk, determining the conformity assessment route required.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
France
Address
240, ALLEE JACQUES MONOD, SAINT PRIEST, France
Website
guerbet.com
Phone
+33472792050
PRRC contact
Gwenaela NAOUR
EUDAMED SRN
FR-MF-000000414
FDA FEI number
3012261967
DUNS number
398197913