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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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Z-0084-2016 - regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray co...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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Z-0083-2016 - regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray con...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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Z-0082-2016 - regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray ...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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Z-0104-2016 - regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedur...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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Z-0081-2016 - regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure t...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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Z-0080-2016 - regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray ...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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Z-0079-2016 - regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray co...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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Z-0077-2016 - regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray contains surg...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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Z-0076-2016 - regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedure tray cont...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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Z-0075-2016 - regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Custom procedur...
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2
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10/07/2015
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Resource Optimization & Innovation Llc
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