BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease. Class II

Reason: Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.

Becton Dickinson & Co. 20130208 Terminated
Distributed: Distributed in the states of CA, FL, GA, NJ, and TX.
Presource PBDS, Knee Arthroscopy, Kit, Circulator Class I

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health, Medical Products & Services 20130326 Terminated
Distributed: Distributed in the states of AR, MS, SC, and TN.
Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit Class I

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health, Medical Products & Services 20130326 Terminated
Distributed: Distributed in the states of AR, MS, SC, and TN.
Presource PBDS, Total Knee, Kit, Circulator Class I

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health, Medical Products & Services 20130326 Terminated
Distributed: Distributed in the states of AR, MS, SC, and TN.
Presource PBDS, Total Joint, Kit, Circulator Class I

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health, Medical Products & Services 20130326 Terminated
Distributed: Distributed in the states of AR, MS, SC, and TN.
Presource PBDS, Total Hip, Kit, Circulator Class I

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health, Medical Products & Services 20130326 Terminated
Distributed: Distributed in the states of AR, MS, SC, and TN.
Presource PBDS, Shoulder Procedure, Kit, Circulator Class I

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health, Medical Products & Services 20130326 Terminated
Distributed: Distributed in the states of AR, MS, SC, and TN.
Presource PBDS, Shoulder Arthroscopy, Kit, Circulator Class I

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health, Medical Products & Services 20130326 Terminated
Distributed: Distributed in the states of AR, MS, SC, and TN.
Presource PBDS, Hand, Kit, Circulator Class I

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health, Medical Products & Services 20130326 Terminated
Distributed: Distributed in the states of AR, MS, SC, and TN.
Presource PBDS, Extremity, Kit, Circulator Class I

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health, Medical Products & Services 20130326 Terminated
Distributed: Distributed in the states of AR, MS, SC, and TN.
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