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FDA MEDWATCH ALERTS

December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter

Summary:

FDA MedWatch Recall - Particulate Matter

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

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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

94–152 of 152 results
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Friday, November 30, 2012

Mindray A3 and A5 Anesthesia Delivery System: Class I Recall - Gasket Leak

Mindray A3 and A5 Anesthesia Delivery System

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Friday, November 09, 2012

Baxter Healthcare Corp. Buretrol Solution Sets: Class 1 Recall - May Not Function as Expected

Baxter Healthcare Corp Buretrol Solution Sets

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Thursday, November 01, 2012

Fungal Meningitis Outbreak Laboratory results from samples of two additional recalled NECC products

Fungal Meningitis Outbreak Laboratory results from samples of two additional recalled NECC products

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Monday, October 22, 2012

Fungal Meningitis Outbreak: FDA Provides NECC Customer List

Fungal Meningitis Outbreak FDA Provides NECC Customer List

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Thursday, October 18, 2012

FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised - Update

FDA Statement on Fungal Meningitis Outbreak Additional Patient Notification Advised Update

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Monday, October 15, 2012

FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised

FDA Statement on Fungal Meningitis Outbreak Additional Patient Notification Advised

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Monday, October 08, 2012

New England Compounding Center (NECC): Potentially Contaminated Medication Fungal Meningitis Outbreak

New England Compounding Center Potentially Contaminated Medication Fungal Meningitis Outbreak

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Friday, August 17, 2012

Hospira Hydromorphone Hydrochloride Injection

Hospira Hydromorphone Hydrochloride Injection

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Friday, August 17, 2012

Hospira Propofol Injectable Emulsion: Recall- Glass Vial Defect

Hospira Propofol Injectable Emulsion

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Friday, June 29, 2012

Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation

Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation

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Wednesday, May 16, 2012

Hydromorphone Hydrochloride Recall

Hydromorphone Hydrochloride Recall

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Wednesday, April 18, 2012

Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume

Customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume. Opioid pain medications such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

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Monday, March 05, 2012

Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Component

FDA notified healthcare professionals and medical care organizations of the Class 1 recall of the listed AEDs which contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy, causing serious adverse health consequences, including death. The unit’s self test may not detect the failure or impending failure of the component.

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Friday, February 24, 2012

Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes: Class 1 Recall - Inadvertent Dislodgement

FDA notified healthcare professionals and medical care organizations about the Class 1 recall of certain lots of these tracheostomy tubes. Difficulty arising from disconnecting accessories from the connectors of the affected tubes may result in excessive force to detach the accessory and the tracheostomy tube may dislodge from the patient. This could lead to serious patient injury or death, especially if no replacement tube is immediately available.

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Monday, January 09, 2012

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

FDA is advising health care professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

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Wednesday, January 04, 2012

Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings

FDA notified healthcare professionals of a Class I recall of Ikaria INOmax DS Drug Delivery System. Erratic nitric oxide (NO) monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals.

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Friday, December 23, 2011

CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation

FDA notified health care professionals of a class I recall of CareFusion AVEA Ventilators. The AVEA ventilator can develop a failure where the ventilator activates a false extended high peak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury or death.

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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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