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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Single Chamber Temporary External Pacemaker, Model 53401
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2
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06/29/2018
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF
These low voltage (LV) devic...
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2
|
06/12/2018
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St Jude Medical Inc.
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PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST
These low voltage (LV) devices are implantable pace...
|
2
|
06/12/2018
|
St Jude Medical Inc.
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PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI
These low voltage (LV) devices are implanta...
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2
|
06/12/2018
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St Jude Medical Inc.
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PM 1260 ASSURITY +
These low voltage (LV) devices are implantable pacemaker pulse generators, inten...
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2
|
06/12/2018
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St Jude Medical Inc.
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PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP
These low voltage (LV) devices are implantable pa...
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2
|
06/12/2018
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St Jude Medical Inc.
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Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional...
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2
|
05/01/2018
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Philips Electronics North America Corporation
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MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602...
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2
|
03/24/2018
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ConMed Corporation
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MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL® Connector, REF/Catalog Number 2602Z
Indicat...
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2
|
03/24/2018
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ConMed Corporation
|
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control® Quik-Combo" Connector, REF/Catalog Nu...
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2
|
03/24/2018
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ConMed Corporation
|