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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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Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems;
Model number...
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2
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09/17/2015
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Intuitive Surgical, Inc.
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Temporary Total Artificial Heart (TAH-t) with Freedom Driver System
REF 595000-001
Product Usa...
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1
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09/17/2015
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SynCardia Systems Inc.
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NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate ae...
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2
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09/17/2015
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Salter Labs
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ACUSON SC2000 Ultrasound System with software versions VB10B and lower;
Model 10433816;
Product ...
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2
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09/17/2015
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Siemens Medical Solutions USA, Inc.
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Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K
For use in performing cardiac ablation proc...
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2
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09/17/2015
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Medtronic Inc. Cardiac Rhythm Disease Management
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The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments.
The Leica ASP200S...
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3
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09/17/2015
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Leica Microsystems, Inc.
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Pointe Scientific Creatinine Reagent
Catalog number C7539-150
in vitro diagnostic
C7539-150 kit ...
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3
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09/16/2015
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Pointe Scientific, Inc.
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CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive m...
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2
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09/16/2015
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Advanced Sterilization Products
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Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitat...
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2
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09/16/2015
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Orthovita, Inc., dBA Stryker Orthobiologics.
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Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use ...
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2
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09/16/2015
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Edward Lifesciences, Llc
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