| Class 1 Device Recall PadPro | |
Date Initiated by Firm | November 06, 2014 |
Date Posted | December 04, 2014 |
Recall Status1 |
Terminated 3 on October 30, 2017 |
Recall Number | Z-0456-2015 |
Recall Event ID |
69752 |
510(K)Number | K014209 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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Product | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, 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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MKJ
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