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FDA MEDWATCH ALERTS

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

Summary:

FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled

Summary:

Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

Summary:

FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

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FDA Alerts and Recalls

AUDIENCE: Surgery, Anesthesia, Neurology, Healthcare Professionals

ISSUE: FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from New England Compounding Center (NECC). FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus.

Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication. That product is preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. CDC’s interim data show that all infected patients received injection with this product.

BACKGROUND: FDA was been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of Registration in Pharmacy have been conducting an inspection of the New England Compounding Center. The firm voluntarily ceased all operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012.

RECOMMENDATION: Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. In addition, FDA requests that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products.

Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, FDA is advising not to use it at this time. This includes all products compounded and distributed at NECC; not just the ones that have been recalled. Please see the CDC website for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

 

Download form

or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, incliding links to the FDA statement, Q&As, and list of recalled products, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm322849.htm


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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Alerts By Date

41–60 of 151 results
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Monday, October 07, 2013

Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall - Defective Cuff Balloon On Endotracheal Airway

Emergency Cricothyrotomy Kit By HH Medical Corporation Recall Defective

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Monday, October 07, 2013

1 Percent Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate

Lidocaine HCL Injection By Hospira Recall Presence Of Dark Particulate

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Wednesday, October 02, 2013

Carefusion Avea Ventilator: Recall - Underreporting Of Tidal Volume If used In Conjunction With Neonatal Hotwire Flow Sensor

Carefusion Avea Ventilato Recall Underreporting Of Tidal Volume If used In Conjunction

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Monday, September 23, 2013

Baxter Dual Luer Lock Caps: Class I Recall - Presence of Loose Particulate Matter Found In Packaging

Baxter Dual Luer Lock Caps Class I Recall Presence of Loose Particulate Matter Found In Packaging

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Friday, September 13, 2013

Leiter's Compounding Pharmacy: Recall - Concerns of Sterility Assurance

Leiters Compounding Pharmacy Recall Concerns of Sterility Assurance

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Thursday, September 12, 2013

GE Healthcare issues urgent medical device correction associated with all Tec 6 and Tec 6 Plus Vaporizers

GE Healthcare issues Urgent Medical Device Correction associated with all Tec 6 and

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Friday, August 30, 2013

Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination

Wellness Pharmacy Inc Products Recall Laboratory Results Indicating Microbial Contamination

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Friday, August 30, 2013

JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor

JCB Laboratories Products Recall Sterility Assurance at Testing Vendor

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Tuesday, August 20, 2013

Aidapak Services LLC, Select Repackaged Pharmaceuticals: Recall - Potential Incorrect Labeling

Aidapak Services LLC Select Repackaged Pharmaceuticals Recall Potential Incorrect Labeling

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Wednesday, August 14, 2013

Hospira Blood Sets: Recall - Instances Of Outer Wall Of Blood Bags Punctured With Piercing Pin

Hospira Blood Sets Recall Instances Of Outer Wall Of Blood

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Monday, August 12, 2013

Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections

Specialty Compounding Sterile Products FDA Alert Bacterial Infections

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Friday, August 02, 2013

Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance

Beacon Hill Pharmacy Voluntary Nationwide Recall of Certain Sterile Products 8-2-13

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Wednesday, July 24, 2013

MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level Sensor

MedStream Programmable Infusion Pump Class 1 Recall

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