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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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Various Pacemaker Packs, Cardio Thoracic Packs
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2
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09/08/2022
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American Contract Systems, Inc.
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The Allura Xper series is intended for use on human patients to perform:
"Vascular, cardiovascular ...
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2
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09/14/2021
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Philips North America Llc
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The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular a...
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2
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09/14/2021
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Philips North America Llc
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Essentio pacemaker, Models:
a) L100
b) L101
c) L110
d) L111
e) L121
f) L131
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2
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07/02/2021
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Boston Scientific Corporation
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Proponent pacemaker, Models:
a) L200
b) L201
c) L209
d) L210
e) L211
f) L221
g) L231
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2
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07/02/2021
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Boston Scientific Corporation
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Accolade pacemaker, Models:
a) L300
b) L301
c) L310
d) L311
e) L321
f) L331
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2
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07/02/2021
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Boston Scientific Corporation
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Altrua 2 pacemaker, Models:
a) S701
b) S702
c) S722
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2
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07/02/2021
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Boston Scientific Corporation
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VALITUDE CRT-P pacemaker, Models:
a) U125
b) U128
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2
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07/02/2021
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Boston Scientific Corporation
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VISIONIST CRT-P pacemaker, Models:
a) U225
b) U226
c) U228
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2
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07/02/2021
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Boston Scientific Corporation
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Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrh...
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2
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05/04/2021
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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