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U.S. Department of Health and Human Services

Class 1 Device Recall PadPro

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  Class 1 Device Recall PadPro see related information
Date Initiated by Firm November 06, 2014
Date Posted December 04, 2014
Recall Status1 Terminated 3 on October 30, 2017
Recall Number Z-0455-2015
Recall Event ID 69752
510(K)Number K014209  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Code Information All Lot Codes
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Rd
Utica NY 13502-5945
For Additional Information Contact Gregory Connell
727-399-5276
Manufacturer Reason
for Recall		 Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
FDA Determined
Cause 2		 Device Design
Action ConMed sent an Urgent Device Correction letter dated November 16, 2014, to all affected consignees via UPS Next Day Air. The letter instructed consignees to notify all end users of the correction. For questions or additional information, consignees were instructed to contact ConMed at 1-727-399-5276 or by e-mail at multifunctionelectrodes@conmed.com. International notices were sent via UPS Priority or equivalent by November 19, 2014.
Quantity in Commerce 174,610 (168,090 US and 6,520 OUS) in total.
Distribution Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PADPRO LLC.
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