BEUDAMED
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    OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.

    FDA Recall
    Terminated ·Insulet Corporation·Product code LZG·September 27, 2013

    Accu-Chek Ultraflex-2 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540972001.

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

    Accu-Chek FlexLink 1 infusion set; 8/80; Ref number 04540816001. (Distributed outside of the U.S. only).

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

    Accu-Chek Ultraflex-1 infusion set; 10 mm (30 cm); (Distributed outside the US only).

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

    Accu-Chek FlexLink 1 infusion set; 10/60; Ref number 04540875001. (Distributed outside of the U.S. only).

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

    Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, 1 cartridge; catalog number 150.0051.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·May 17, 2004

    Animas 2020 Insulin Infusion Pumps Intended use:deliver insulin therapy

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·March 18, 2010

    Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·July 21, 2003

    Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·July 15, 2005

    OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·March 1, 2012

    T:slim Insulin Delivery System Insulin Infusion Pump

    FDA Recall
    Terminated ·Tandem Diabetes Care Inc·Product code LZG·January 10, 2014

    Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·October 25, 2012

    Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

    FDA Recall
    Terminated ·Product code LZG·February 1, 2021

    One Touch Ping Glucose Management Systems Intended use: deliver insulin therapy

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·March 18, 2010

    Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·July 21, 2003

    ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS

    FDA Recall
    Terminated ·Medtronic MiniMed·Product code LZG·April 27, 2005

    Isulin Pump. Model IR1250

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·October 31, 2005

    Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·March 10, 2008

    Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, box of 25; catalog number 300.0420.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·May 17, 2004

    Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25; manufactured for Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 3001061.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·May 17, 2004