Thursday, November 21, 2024

NJSFAC 15b3

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  • INFONOTICE: Fentanyl Safety Recommendations Open or Close

    In light of recent incidents in the news, the White House has released guidelines and safe practices to deal with the growing concern of illicit use of the opiod drug FENTANYL when responding to emergency calls.  Use the links below for the poster and further details:

    Federal Recommendations on Fentanyl Precautions for EMS

     

  • URGENT DEVICE RECALL: Infant/Child AED Pads for Physio-Control Open or Close

    To all users of PHYSIO-CONTROL LIFEPAK EXPRESS®, CR®, Plus AED, Model 1000 and Model 500 BiPhasic AEDs:  There is a voluntary recall of specific production lots of Infant/Child defibrillation electrodes produced by Cardinal Health.  Your attention to this recall is required.

    Please read the attached PDF document and take action as approriate.

  • EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device Open or Close

    AUDIENCE: Consumer, Pharmacy

    ISSUE: Mylan N.V. announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets.

    Read More
  • FDA issues Safety Alert on Lifepak 1000 defibrillators Open or Close

    The Food and Drug Administration (FDA) on January 14 issued a Safety Alert announcing the voluntary field action by Physio-Control (Redmond, Washington) notifying its customers to immediately remove and reinstall batteries in the Lifepak 1000 defibrillator.

    The company has received 34 reports of customers attempting to use the defibrillator, and the device shut down unexpectedly because of an intermittent connection between the battery and device electrical contacts. The intermittent connection is a result of wear and subsequent oxidation formation between the battery and electrical contacts, according to the company.

    Physio-Control is aware of 8 adverse events related to this issue.

  • PRODUCT RECALL: Nurse Assist Inc. IV Flush Syringes Open or Close

    Nurse Assist, Inc. announced this week that it is voluntarily recalling all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia bloodstream infections with the product. According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of Burkholderia cepacia on people "vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis." If a patient is having symptoms, contact your health care provider.

    Product Numbers 1203 (3 ml syringe), 1205 (5 ml syringe), and 1210 (10 ml syringe) are packaged 30 syringes to an inner carton and six inner cartons in a case (180 syringes). For product number 1210-BP (10 ml syringe), 100 syringes are packaged in an inner carton with four inner cartons in a case (400 syringes). Lot code information can be found on the outer case panel, the back panel of the inner carton, and on each syringe label.

    The lots being recalled were distributed to customers and distributors between 02/16/16 and 09/30/16. Product can be identified by the labeling on the packaging and device. Nurse Assist is directing customers not to use the product from recalled lots. Recalled product should be returned for credit by contacting Nurse Assist Customer Service at 1-800-649-6800 ext. 10, Monday through Friday, between the hours of 8am and 5pm, Central Time.

    Nurse Assist voluntarily recalled its I.V. Flush Syringes after becoming aware of patients that developed Burkholderia cepacia bloodstream infections while receiving intravenous care using prepackaged saline flushes from Nurse Assist

    Nurse Assist is notifying its distributors and customers via email, phone call, and certified mail. Customers will receive instructions for returning product. For freight collect shipping information, please contact the Customer Service Team at 1-800-649-6800 ext. 10.

    Nurse Assist is actively investigating the possible link to the infections with the Food and Drug Administration, the U.S. Centers for Disease Control, and various state health departments to ensure that the products are safe for their intended use. Until an investigation can be completed, Nurse Assist urges all healthcare facilities with affected product to discontinue use and return the product to the supplier.

    Consumers with questions may contact the company via telephone at 1-800-649-6800 ext. 10, Monday through Friday, between the hours of 8am and 5pm, Central Time. Consumers may also contact the company via email at ProductRemovalInfo@nurseassist.com.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    http://www.fda.gov/safety/recalls/ucm523959.htm

    reprinted from BURLCOLINCS

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