Friday, March 29, 2024

recalls

  • Dräger Medical Inc. Recalls Emergency Transport Ventilators

    Dräger Medical Inc. Recalls Emergency Transport Ventilators Due to a System Error that may lead to a Halt in Ventilation Therapy

    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

    Recalled Devices: 
    • Dräger Oxylog 2000 plus, Oxylog 3000, and Oxylog 3000 Plus Ventilator
    • Catalog numbers: 5705080, 2M86300, 2M86965, 5704813, 5704831
    • Distribution Dates: April 1, 2007 to December 12, 2015
    • Devices Recalled in the U.S.: 117 distributed in Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
    Device Use

    The Dräger Oxylog Emergency Transport Ventilators provide constant breathing support for adults and children. These ventilators are used in hospitals or during patient transport. 

    Image of the Oxylog 3000 plus.
    Oxylog® 3000 plus

    Reason for Recall

    Dräger is recalling the Oxylog Emergency Transport Ventilators because an electrical issue may cause the device to stop working if the control knobs (adjustment potentiometers) are not regularly used.

    If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.

    Who May be Affected
    • Health care providers using Dräger Oxylog 2000 plus, Oxylog 3000, and Oxylog 3000 Plus Ventilators
    • All patient groups who may be given breathing support with these ventilators
    What to Do

    Dräger sent a letter to all customers with affected devices on December 21, 2015, informing them of this issue.

    The letter provides the following instructions to release the electrical contact resistance in the control knobs:

    • Turn the device off
    • Rotate all control knobs at least 10 times to the left and right stop (minimum and maximum value)
    Contact Information

    Customers with questions about this recall may call Dräger at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349).

    Customers with questions regarding the operation and/or servicing of Dräger Oxylog ventilators may contact Dräger Service Technical Support at 1-800-543-5047 (press 4 at the prompt).

    Date Recall Initiated:

    December 22, 2015

    How do I report a problem?

    Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program  either online, by regular mail or by FAX.

  • EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device

    AUDIENCE: Consumer, Pharmacy

    ISSUE: Mylan N.V. announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets.

  • Medtronic Recalls Battery Pack

    Medtronic Respiratory and Monitoring Solutions Recalls Battery Pack Used on Patient Monitors Due to Potential Fire Risk

    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

    Recalled Product:

    • Battery Pack used on Capnostream™ 20 and Capnostream™ 20p Patient Monitors
    • Model numbers: 016400 and 010520
    • Manufacturing dates: April 1, 2014 to February 3, 2016
    • Distribution dates: April 1, 2014 to February 3, 2016
    • Devices recalled in the U.S.: 9,817 battery packs nationwide, including Washington D.C.

    Device Use

    The battery pack powers the monitor of the Capnostream™ 20 and Capnostream™ 20p when electrical power is not available. The Capnostream™ 20 and Capnostream™ 20p are used to monitor vital signs and levels of oxygen and carbon dioxide in neonatal, pediatric, and adult patients. The patient monitors and battery packs are used in hospitals or during patient transport.

    Reason for Recall

    Medtronic Respiratory & Monitoring Solutions is recalling the battery packs due to a manufacturing defect that causes an increase in temperature within battery that may cause a fire in the system monitor.

    The use of affected products may cause serious adverse health consequences, including death.

    Who May be Affected

    • Patients whose vital signs are being monitored using the Capnostream™ 20 and Capnostream™ 20p supplied with the defective battery pack
    • Health care providers using the Capnostream™ 20 and Capnostream™ 20p supplied with the defective battery pack

    What to Do

    On April 15, 2016, Medtronic Respiratory & Monitoring Solutions sent an "Urgent: Medical Device Recall" letter to affected customers. The letter instructed customers to:

    • Identify, remove, and appropriately dispose of affected battery packs
    • Prepare the monitoring units to work without the battery pack by following the instructions provided attached with the letter
    • Avoid using the monitoring units for patient transport
    • Complete and return the acknowledgement and receipt form by email at This email address is being protected from spambots. You need JavaScript enabled to view it.

    New batteries will be provided free of charge once the acknowledgment and receipt form are received.

    Contact Information

    Customers can contact Medtronic Respiratory & Monitoring Solutions at 1-800-635-5267. At the prompt, press 1, then 1.

    Date Recall Initiated:

    April 13, 2016

    How do I report a problem?

    Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.