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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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Cardiac Resynchronization Therapy (CRT) Leads
Trade Name: QuickFlex, QuickFlex XL
Model Numbe...
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2
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05/03/2012
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St Jude Medical CRMD
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Cardiac Resynchronization Therapy (CRT) Leads.
Trade Name: QuickSite, QuickSite XL
Model Numb...
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2
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05/03/2012
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St Jude Medical CRMD
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Unify, Model No. CD3231-40, CD3231-40Q.
Unify Quadra, Model No. CD3249-40, CD3249-40Q.
Unify Assur...
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1
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10/21/2016
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St Jude Medical Inc.
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Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40...
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1
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10/10/2017
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St Jude Medical Inc.
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Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1
The Merlin Patient Care System (...
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2
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06/12/2018
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St Jude Medical Inc.
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Promote Quadra, Sterile EO, Model # / Part #:
CD3221-36/100025054, 60019195;
CD3223-36P/10001376...
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2
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06/29/2018
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St Jude Medical Inc.
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Promote, Sterile EO, Model #/ Part #:
3207-30/60010740-207, 60010740-407;
3207-36/60010743-207, ...
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2
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06/29/2018
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St Jude Medical Inc.
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Quadra Assura, Sterile EO, Model #/ Part #:
CD3265-40/100042335, 100059846;
CD3265-40Q/100042336,...
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2
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06/29/2018
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St Jude Medical Inc.
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Unify, Sterile EO, Model #/ Part #:
CD3231-40/100029240, 100030104, 100041904;
CD3231-40Q/100029...
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2
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06/29/2018
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St Jude Medical Inc.
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Unify Assura, Sterile EO, Model #/ Part #:
CD3257-40/100042333, 100059944;
CD3257-40Q/100042334,...
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2
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06/29/2018
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St Jude Medical Inc.
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