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Lumbar Drainage Catheter Kit (Codman) – CSF Drainage Issue (2014)

tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)

Class IIModerate

FDASep 15, 2014Nationwide• Codman & Shurtleff, Inc.

Topiramate (Zydus) – Tablet Mix-up (2014)

Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Class IIModerate

FDASep 15, 2014Nationwide• Zydus Pharmaceuticals USA Inc

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Lumbar Drainage Catheter Kit (Codman) – CSF Drainage Issue (2014)

Topiramate (Zydus) – Tablet Mix-up (2014)

Tarceva (Astellas) – Dissolution Specification Failure (2014)

Expression Information Portal (Invivo) – Display Freezing (2014)

Amiodarone HCl Injection (Mckesson) – Temperature Storage Issue (2014)

nordicICE Software (NordicNeuroLab) – Orientation Labeling Error (2014)

Prescription Safety Lenses (Eyemart) – Specification Failure (2014)

Human IgG4 Reagent (Binding Site) – Test Result Risk (2014)

Patient Side Cart (Intuitive Surgical) – Motor Sensor Failure (2014)

Human Subclass Kit (Binding Site) – Test Result Issue (2014)

Human IgG4 Reagent (Binding Site) – Test Result Inaccuracy (2014)

Human IgG4 Kit (Binding Site) – Test Result Issue (2014)

Human IgG Subclass Reagent (Binding Site) – Test Result Problem (2014)

Human IgG Subclass Reagent (Binding Site) – Test Result Problem (2014)

Ingenuity CT Scanner (Philips) – Image Labeling Error (2014)

ARCHITECT Total T3 Reagent (Abbott) – Light Unit Variation (2014)

MininephThl IgG4 Kit (Binding Site) – Test Result Inaccuracy (2014)

I Color Crazy Lens (Intertrade) – Bacterial Risk (2014)

Frozen Onion Rings (McCain Foods) – Glass Contamination (2014)

I Color Complete Lens (Intertrade) – Bacterial Contamination (2014)