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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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Alto implantable cardioverter defibrillator
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2
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11/04/2004
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ela Medical Llc
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Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular a...
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2
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09/24/2005
|
ela Medical Llc
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Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular an...
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2
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09/24/2005
|
ela Medical Llc
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INTENSIA Models: VR 124, DR 154, CRT-D 174
Product Usage:
OVATIO VR 6250, OVATIO DR 6550, PARAD...
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2
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05/18/2017
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Sorin Group Italia SRL - CRF
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Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6.
These lead models are...
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2
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03/08/2013
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Sorin Group USA, Inc.
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ORCHESTRA/ORCHESTRA PLUS Programmer
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2
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01/22/2014
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Sorin Group Italia S.r.l.
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OVATIO Models: VR 6250, DR 6550, CRT 6750.
Product Usage:
OVATIO VR 6250, OVATIO DR 6550, PARA...
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2
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05/18/2017
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Sorin Group Italia SRL - CRF
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PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF ...
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2
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05/18/2017
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Sorin Group Italia SRL - CRF
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Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. ...
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2
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06/22/2011
|
ela Medical Llc
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Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrill...
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2
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09/28/2017
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Sorin Group Italia SRL - CRF
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