Drugs & medicalClass II

Defibtech, LLC recalls Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View…

Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could…

Read the official notice →
Date
2024-12-04
Country
United States
Brand
Defibtech
Product
Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View…
Classification
Class II
Units
Ireland
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Defibtech recalls

  1. 2025-05-07
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    Defibtech, LLC recalls Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1…

    It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…

    FDA · DeviceDefibtech, LLCInternational Only: Switzerland.Official notice →
  3. 2024-12-04
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    Defibtech, LLC recalls Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on…

    Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead…

    FDA · DeviceDefibtech, LLCIrelandOfficial notice →
  5. 2024-08-21
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    Defibtech, LLC recalls RMU-2000 Automated Chest Compression Device

    Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.

    FDA · DeviceDefibtech, LLCDomestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to JapanOfficial notice →
  7. 2023-04-05
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    Defibtech, LLC recalls DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

    A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.

    FDA · DeviceDefibtech, LLCUS Nationwide distribution.Official notice →
All 5 Defibtech recalls →

Other drugs & medical recalls in the United States

  1. 2024-12-04
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    Smith & Nephew Medical, Ltd. recalls RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound…

    Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

    FDA · DeviceSmith & Nephew Medical, Ltd.U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: CanadaOfficial notice →
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    MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON…

    The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

    FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide. Bermuda, Canada, Panama, UAE, US Virgin IslandsOfficial notice →
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    KCI USA, INC. recalls V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound…

    Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

    FDA · DeviceKCI USA, INC.Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL,…Official notice →
  5. US
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    Defibtech, LLC recalls Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on…

    Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead…

    FDA · DeviceDefibtech, LLCIrelandOfficial notice →
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    Hologic, Inc recalls BioZorb Marker. Radiographic soft tissue marker.

    Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

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See all drugs & medical recalls →