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Showing 22521–22540 of 29086 results

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Drill Set (Straumann) – Incorrect Drill Risk (2014)

Drill set may contain incorrect drill.

Class IIModerate

FDAOct 27, 2014Nationwide• Straumann USA, LLC

Monastery Washed Rind Cheese (Saxon Cheese) – E. coli contamination (2014)

Saxon Cheese LLC is recalling one lot of GreenFields Monastery Washed Rind Wisconsin handcrafted Cheese because product tested positive for E.coli.

Class IIModerate

FDAOct 27, 2014WI• Saxon Cheese, LLC

Dual Switch Valve (Aesculap) – Incorrect Labeling (2014)

Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue.

Class IIModerate

FDAOct 24, 2014IN, KS• Aesculap, Inc.

Thai Coconut Water (Exotic Superfoods) – processing concern (2014)

It appears that these batches were not subjected to 5-log reduction as part of their processing.

Class IIModerate

FDAOct 24, 2014CA, CO, IN• Exotic Superfoods New York, Inc.

Preserved Plum Candy (Tristar Food) – illegal additives (2014)

Undeclared Allergen

Dried Plum Candy contains non-permitted cyclamates, undeclared benzoic acid and undeclared Yellow #5.

Class IIModerate

FDAOct 24, 2014NY• Tristar Food Wholesale Co Inc

GE Discovery MR950 MRI (GE) – Laser Label Missing (2014)

The alignment lasers are missing the labels required by radiation safety regulations.

Class IIModerate

FDAOct 24, 2014CA• GE Healthcare

Meropenem Injection (Hospira) – container defect (2014)

Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.

Class IIModerate

FDAOct 24, 2014Nationwide• Hospira Inc.

Titan Reverse Shoulder System (Integra) – Manufacturing Error (2014)

Laceration Risk

A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the reverse of what it should be.

Class IIModerate

FDAOct 24, 2014Nationwide• Integra LifeSciences Corp.

Relief ACP Oral Care Gel (Discus Dental) – Incorrect Gel Fill (2014)

Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.

Class IIModerate

FDAOct 24, 2014Nationwide• Discus Dental LLC

Abbott m2000sp System (Abbott) – Software Compatibility (2014)

Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected.

Class IIModerate

FDAOct 23, 2014Nationwide• Abbott Molecular

Glucose Hexokinase Reagent (JAS) – Performance Inconsistency (2014)

Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.

Class IIModerate

FDAOct 23, 2014CA, FL, GA +8 more• JAS Diagnostics Inc.

JResultNet Drivers (Data Innovations) – Software Patient Mix-up (2014)

Software issue resulting in the results of one patient potentially being associated with another.

Class IIModerate

FDAOct 23, 2014Nationwide• Data Innovations, LLC

Pacemaker Tray (Centurion) – Particulate Contamination (2014)

According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.

Class IIModerate

FDAOct 23, 2014Nationwide• Centurion Medical Products Corporation

Diagnostic Imaging Tray (Centurion) – Particulate Contamination (2014)

According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.

Class IIModerate

FDAOct 23, 2014Nationwide• Centurion Medical Products Corporation

Chest Tube Tray (Centurion) – Particulate Contamination (2014)

According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.

Class IIModerate

FDAOct 23, 2014Nationwide• Centurion Medical Products Corporation

Odwalla Chocolate Protein Shake (Coca-Cola) – Potential Spoilage (2014)

There is the potential that some of the bottles could exhibit spoilage before end of shelf life.

Class IIModerate

FDAOct 23, 2014Nationwide• Coca-Cola Company (The)

Oxoid Legionella Latex Test (Remel) – False Negative Risk (2014)

A reagent within the test may return false negative results.

Class IIModerate

FDAOct 23, 2014Nationwide• Remel Inc

Nerve Block Tray (Centurion) – Particulate Contamination (2014)

According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.

Class IIModerate

FDAOct 23, 2014Nationwide• Centurion Medical Products Corporation

ROTROL P Control (TEM Systems) – Partial Vial Filling (2014)

Some of vials were found to be partially filled.

Class IIModerate

FDAOct 23, 2014Nationwide• TEM Systems Inc

Oxoid Legionella Pneumo Test (Remel) – False Negative Risk (2014)

A reagent within the test may return false negative results.

Class IIModerate

FDAOct 23, 2014Nationwide• Remel Inc

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