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HSAG ESRD Alerts, Recalls, and Notices

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  • Outbreak of Hepatitis A Virus (HAV) Infections among Persons Who Use Drugs and Persons Experiencing Homelessness

    Tuesday, June 12, 2018

    The Centers for Disease Control and Prevention (CDC) and state health departments are investigating hepatitis A outbreaks in multiple states among persons reporting drug use and/or homelessness and their contacts. This Health Alert Network (HAN) Advisory alerts public health departments, healthcare facilities, and programs providing services to affected populations about these outbreaks of hepatitis A infections and provides guidance to assist in identifying and preventing new infections.

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  • Class 2 Device Recall Liberty Select Cycler

    Friday, June 8, 2018

    Fresenius Technical Service identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.

    On 01/25/2018, the recalling firm sent Urgent Medical Device Correction letters to affected Home Therapy Nurse Managers (HTNs). On 01/31/2018, the firm sent letters to affected patients. The letters informed customers of the recall and stated that patients who are considered "slow drainers" and experience M65 Scale warnings during one or more drain cycles are at increased risk.

    On 03/29/2018, the firm sent out a second Urgent Medical Correction Letter to HTNs, followed by a patient communication sent on 04/02/2018. In the second communication, the firm amended that slow drainers can develop Overfill/IIPV even without receiving M65 scale warning.

    Health care providers and patients using the device were advised to monitor drain rates and address the reasons for slow draining, such as constipation, fibrin deposition, peritonitis, and catheter malposition. Health care providers were advised to continue to review risk factors and symptoms of Overfill/IIPV with PD nursing staff and patients with extended drain times.

    The firm is not requesting the return of the recalled device at this time. For additional information and alternative treatment options, please contact the FMCRTG Medical Information Line at 1-855-616-2309. Hours of operation are 8:30AM-5:00PM (EST), Monday - Friday. Online requests may be submitted at any time at www.fmcna-medinfo.com.

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  • Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

    Friday, June 8, 2018

    Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

    In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. The risk is reduced by the possibility of detection, as the labeling contains a clear statement directing visual inspection of the product for particulate matter and discoloration prior to administration. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

    Naloxone Hydrochloride, an opioid antagonist, is indicated for the complete or partial reversal of opioid depression. It is also indicated for the diagnosis of known or suspected opioid overdosage, and as an adjunctive agent for the management of septic shock. It is available as a sterile solution for intravenous (IV), intramuscular (IM), and subcutaneous (SC) administration. Naloxone is supplied in a Carpuject single-use cartridge with a 1 mL fill for use with the Carpuject syringe system.
    The NDC, Lot Number, Expiration Date, Strength and Configuration details for Naloxone Hydrochloride Carpuject Injection is indicated below. Product lots were distributed nationwide to wholesalers/distributors/hospitals in the United States, Puerto Rico, and Guam from February 2017 to February 2018.

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  • Update – CDC Recommendations for Managing and Reporting Shigella Infections with Possible Reduced Susceptibility to Ciprofloxacin

    Friday, June 8, 2018

    This Health Alert Network (HAN) Update provides current recommendations on management and reporting of Shigella infections that have been treated with ciprofloxacin or azithromycin and resulted in possible clinical treatment failure. This is a follow-up to HAN 401: CDC Recommendations for Diagnosing and Managing Shigella Strains with Possible Reduced Susceptibility to Ciprofloxacin.

    The Centers for Disease Control and Prevention (CDC) continues to identify an increasing number of Shigella isolates that test within the susceptible range for the fluoroquinolone antibiotic ciprofloxacin (minimum inhibitory concentration [MIC] values of 0.12-1 μg/mL), but harbor one or more resistance mechanisms. CDC remains concerned about potential clinical failures with fluoroquinolone treatment.

    Clinicians should carefully monitor patients with Shigella infections who require fluoroquinolone treatment and report any possible treatment failures. If treatment failure is suspected, clinicians should submit a stool specimen for antimicrobial susceptibility testing, and consider consulting an infectious disease specialist to identify best treatment options.

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  • HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller

    Tuesday, June 5, 2018

    Medtronic is recalling the HeartWare HVAD because of the possibility for an interruption to occur in the electrical connection between the system’s power source (battery, AC adapter, or DC adapter) and the HVAD controller. This interruption to the electrical connection, which occurs when the power source is still physically connected, is caused by oxidation on the connecting surfaces between the power source connector and the controller’s power source socket. Interruptions to the electrical connection could cause unintended intermittent electrical disconnection, which could result in a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness, or death.

    A full list of affected devices is available in the FDA recalls database.

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  • HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

    Wednesday, May 23, 2018

    The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

    • Recalled Products: HeartMate 3™ Left Ventricular Assist System
    • Model/Item Numbers: Catalog # 106524US (U.S. commercial), 106524 (U.S. Investigational Device Exemption number), 10652INT (international)
    • Lot Numbers: All lots
    • Manufacturing Dates: All
    • Distribution Dates: September 2, 2014 to present
    • Devices Recalled in the U.S.: 4,878 units nationwide

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  • Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

    Thursday, May 10, 2018

    AuroMedics Pharma is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose vials, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients.

    In the event the particulate is administered to the patient, it may result in local site reaction, phlebitis, pulmonary granuloma, occlusion of blood vessels, thromboembolic events and systemic immune response. Patients with vascular disease may be at particular risk of embolic events which could cause permanent impairment or damage to a body structure or function. The risk is reduced by the possibility of detection.

    To date, AuroMedics Pharma has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots.  

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  • Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter

    Thursday, May 10, 2018

    AuroMedics Pharma is voluntarily recalling two lots of Piperacillin and Tazobactam for Injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level.

    The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.

    To date, AuroMedics Pharma has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots.

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  • Outbreak Alert Update: Potential Life-Threatening Vitamin K-Dependent Antagonist Coagulopathy Associated With Synthetic Cannabinoids Use

    Tuesday, May 1, 2018

    This COCA Clinical Action updates the message sent on April 5, 2018: https://content.govdelivery.com/accounts/USCDC/bulletins/1e6dac3

    Since the index case was identified on March 8, 2018 in Illinois, at least 160 people have presented to Healthcare facilities with serious unexplained bleeding. The preponderant number of patient presentations were in Illinois with other cases being reported from Florida, Indiana, Kentucky, Maryland, Missouri, Pennsylvania, Virginia, and Wisconsin. Laboratory investigation confirms brodifacoum exposure in at least 60 patients. There are at least 3 fatalities. At least 7 synthetic cannabinoids product samples related to this outbreak have tested positive for brodifacoum. At least one synthetic cannabinoids product has tested positive for both synthetic cannabinoid AB-FUBINACA and brodifacoum.

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  • Liberty Select Cycler Recall

    Tuesday, May 1, 2018

    On 01/25/2018, Fresenius Medical Care Renal Therapies Group, LLC sent Urgent Medical Device Correction letters to affected Home Therapy Nurse Managers (HTNs). On 01/31/2018, the firm sent letters to affected patients. The letters informed customers of the recall and stated that patients who are considered "slow drainers" and experience M65 Scale warnings during one or more drain cycles are at increased risk.

    On 03/29/2018, the firm sent out a second Urgent Medical Correction Letter to HTNs, followed by a patient communication sent on 04/02/2018. In the second communication, the firm amended that slow drainers can develop Overfill/IIPV even without receiving M65 scale warning.

    Health care providers and patients using the device were advised to monitor drain rates and address the reasons for slow draining, such as constipation, fibrin deposition, peritonitis, and catheter malposition. Health care providers were advised to continue to review risk factors and symptoms of Overfill/IIPV with PD nursing staff and patients with extended drain times.

    The firm is not requesting the return of the recalled device at this time. For additional information and alternative treatment options, please contact the FMCRTG Medical Information Line at 1-855-616-2309. Hours of operation are 8:30AM-5:00PM (EST), Monday - Friday. Online requests may be submitted at any time at www.fmcna-medinfo.com.

     

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