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MEETINGS / EVENTS

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October 13 - 17 2012, 12:00 AM - 12:00 AM

ANESTHESIOLOGY 2012

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FDA MEDWATCH ALERTS

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May 16, 2012

Hydromorphone Hydrochloride Recall

Summary:

Hydromorphone Hydrochloride Recall

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

Summary:

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.

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

Summary: 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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FDA Alerts and Recalls

Alerts By Date

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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.

view details »

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.

view details »

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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Thursday, January 12, 2012

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

FDA notified health care professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm.  Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

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Thursday, January 12, 2012

Bedford Laboratories Vecuronium Bromide And Polymyxin B For Injection USP For Injection: Recall - Glass Particles

Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed.

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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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Thursday, September 15, 2011

Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms

FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics).

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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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Friday, May 06, 2011

Needleless Pre-Filled Glass Syringes: Drug Safety Communication - Compatibility Problems With Needleless Intravenous Access Systems

The FDA recommends that, to reduce the potential risks to patients, healthcare professionals and risk managers stock crash carts, ambulances, and emergency rooms with adenosine and amiodarone supplied in vials or pre-filled plastic syringes, if possible. The use of needleless pre-filled glass syringes in emergency situations should be avoided.

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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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About ASA: The American Society of Anesthesiologists is an educational, research and scientific association of physicians organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient. Since its founding in 1905, the Society's achievements have made it an important voice in American Medicine and the foremost advocate for all patients who require anesthesia or relief from pain.