ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
FDA Recall Z-0455-2015 · Posted 2014-12-04
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Recalling FirmConMed Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2014-11-06
Date Terminated2017-10-30
Product Quantity174,610 (168,090 US and 6,520 OUS) in total.
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.
Firm 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 [email protected]. International notices were sent via UPS Priority or equivalent by November 19, 2014.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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