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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 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

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

Summary:

FDA MedWatch Intravia Containers by Baxter 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

122–150 of 150 results
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Friday, November 04, 2011

CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation

FDA notified health care professionals of a Class I recall of all EnVe Ventilator model 19250-001, manufactured between December 2010 and May 2011, due to potential defects that can interrupt ventilation to the patient.

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Monday, September 12, 2011

Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance

Medtronic and FDA notified healthcare professionals of a Class I recall of the SynchroMed II Infusion system. Medtronic’s analysis of the problem indicates it is related to the formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms.

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Wednesday, August 03, 2011

GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH): Class I Recall

FDA notified healthcare professionals of a Class I recall of GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits. The HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.

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Monday, June 27, 2011

Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled

Qualitest and FDA is notifying pharmacists and patients of a recall to the retail level of specific lots of Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets due to possibility that the recalled bottles may contain incorrect tablets, and patients may unintentionally take butalbital and caffeine instead of hydrocodone.

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Monday, June 27, 2011

Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets

Endo Pharmaceuticals and FDA notified pharmacists and patients of a nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg because some bottles may contain different strength tablets, resulting in patients taking more than the intended acetaminophen dose.

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Tuesday, June 07, 2011

Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient

Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

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Tuesday, May 10, 2011

Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock

Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.

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Thursday, March 03, 2011

Cook Inc., Central Venous Catheter Trays

FDA notified healthcare professionals of leaks in the plunger luer detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility. This may lead to serious adverse health consequences and/or death.

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Thursday, January 13, 2011

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication

FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.

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Monday, January 10, 2011

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose

Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product.

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Monday, January 03, 2011

Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials

The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials. This product is being recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/ 3 mL and therefore, represents a potential significant health hazard. "read more"

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Friday, December 24, 2010

Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product

American Regent and FDA notified healthcare professionals of the nationwide recall of specific lots of Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30 mL Multiple Dose Vial because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates.

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Thursday, November 04, 2010

Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall - Motor Encoder Failures

FDA and Hospira notified healthcare professionals of a Class 1 recall of these infusion pump products due to motor encoder failures in the pumping mechanism that causes the infuser to cease operation. Delay or interruption of therapy may result in serious injury or death in: patients receiving critical therapy, pediatric patients, and neonates.

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Wednesday, August 25, 2010

Ikaria® Recalls INOMAX® DS Drug-Delivery System

Ikaria® Recalls INOMAX® DS Drug-Delivery System

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Monday, August 02, 2010

Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

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Monday, August 02, 2010

NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter

NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter

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Thursday, July 22, 2010

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

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Friday, July 09, 2010

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

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Thursday, May 13, 2010

GE Healthcare Aisys and Avance Anesthesia Systems: Recall

GE Healthcare Aisys and Avance Anesthesia Systems: Recall

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Friday, May 07, 2010

Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall

Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall

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Wednesday, May 05, 2010

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change

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Tuesday, May 04, 2010

Baxter Colleague Infusion Pumps: FDA Ordering Recall

Baxter Colleague Infusion Pumps: FDA Ordering Recall

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Saturday, April 24, 2010

Coviden Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

Coviden Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

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Thursday, April 22, 2010

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

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Wednesday, February 10, 2010

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

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