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U.S. Department of Health and Human Services

Class 2 Device Recall Defibtech

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 Class 2 Device Recall Defibtechsee related information
Date Initiated by FirmOctober 14, 2024
Date PostedNovember 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0504-2025
Recall Event ID 95594
PMA NumberP160032 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductDefibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
Code Information UDI-DI: 00815098020447, DDP-2001 adult defibrillation pads, single pack; 30815098020448, DDP-2001 adult defibrillation pads, 10 pairs; 50815098020442, DDP-2001 adult defibrillation pads, 40 pairs
Recalling Firm/
Manufacturer		 Defibtech, LLC
741 Boston Post Rd
Suite 201
Guilford CT 06437-2714
For Additional Information ContactDefibtech Customer Service
203-453-6654
Manufacturer Reason
for Recall		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 potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
FDA Determined
Cause 2		Under Investigation by firm
ActionDefibtech issued Urgent Field Safety Notice on 10/14/24 by e-mail to the Irish Market h via the Distributor Oxygen Care Ltd. titled: Unauthorized Label Applied to Defibtech, LLC's Automated External Defibrillator (AED} Pads within the Irish Market. Letter states reason for recall, health risk and action to take: Actions to be taken by the Customer/User: 1. Check the label of your Defibtech AED Pads. Please review Attachment B which clearly shows authorised labelled Defibtech AED Pads versus unauthorised labelled Defibtech AED Pads. 2. Please confirm receipt of this notice by completing Attachment C "Customer Reply Form", attached to this notice, and return to Oxygen Care, Ltd (our new official Irish Distributor) so that our records may be updated. 3. If an unauthorised label applied to Defibtech AED Pads is confirmed, please urgently return the Defibtech AED Pads along with the completed "Customer Reply Form" to Oxygen Care. Upon receipt of the unauthorized labelled Defibtech AED Pads, Oxygen Care will send a replacement set of authorised labelled Defibtech AED Pads to you at no charge: Oxygen Care Ltd.: Email: Sales@ oxyge n-care.ie Phone: 01 2769700 Address: 2 Holfeld Business Park, Kilmacanogue. Co. Wicklow. Eircode A98 NP27 4. If you have transferred the Defibtech AED Pads to another entity or department, please contact Oxygen Care as per the above contact details. The unauthorised labelled Defibtech AED pads were re-labelled with expiration dates beyond the shelf life of the Defibtech AED Pads. The affected Defibtech AED Pads should not be used. Defibtech will continue to work closely with regulatory authorities toward the resolution of this issue. Defibtech is committed to patient safety and is focused on providing the highest level of customer satisfaction. We appreciate your cooperation and sincerely apologize for any inconvenience this may cause you.
Quantity in Commerce22,294 total
DistributionIreland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MKJ
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