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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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3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System
The Tiger Cannulated...
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2
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08/24/2015
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Trilliant Surgical Ltd.
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CARESTREAM DRX-EVOLUTION X-Ray System
Product Usage:
The device is a permanently installed diag...
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2
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08/22/2015
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Carestream Health Inc
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Dimension Vista B®2-Microglobulin Flex Reagent Cartridge (B2MIC);
Product Usage: The B2MIC meth...
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2
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08/22/2015
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Siemens Healthcare Diagnostics, Inc.
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cobas b 123 Fluid Pack COOX REF 05169992001 200
Product Usage:
The cobas b 123 POC system is a f...
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2
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08/21/2015
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Roche Diagnostics Operations, Inc.
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cobas b 123 Fluid Pack COOX REF 05170036001 400
Product Usage:
The cobas b 123 POC system is a f...
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2
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08/21/2015
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Roche Diagnostics Operations, Inc.
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Covidien Argyle Infant Heel Warmers (no tab)
Item Code: MH00002N
Product Usage: Intended for app...
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2
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08/21/2015
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Covidien LLC
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Covidien Argyle Infant Heel Warmers (with tab)
Item Code: MH00002T
Product Usage: Intended for a...
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2
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08/21/2015
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Covidien LLC
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Otto Bock Healthcare Products GmbH Genium X3
Model Number: 3B5-2, Manufacturer Otto Bock Healthcare...
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2
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08/21/2015
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Otto Bock Healthcare Product
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Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of g...
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2
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08/21/2015
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Medtronic MiniMed Inc.
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ExacTrac 6.0.x
Patient Positioning System, Radiation therapy.
Intended to be used to place patie...
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2
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08/21/2015
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Brainlab AG
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