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HSAG ESRD Alerts, Recalls, and Notices

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  • Prismaflex Control Unit. Dialyzer Recall

    Thursday, April 19, 2018

    Baxter Healthcare Corporation is recalling the Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. Baxter has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.

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  • Class 2 Device Recall 2008 Series Hemodialysis Machine

    Friday, April 13, 2018

    Fresenius Medical Care Renal Therapies is recalling its dialyzer, high permeability with or without sealed dialysate system, 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.

    When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

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  • BD Vacutainer Blood Collection Tubes Class I Recall

    Tuesday, March 27, 2018

    BD is recalling their Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the rubber tube stopper that interferes with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology. ASV is the methodology used in Magellan Diagnostics’ LeadCare Testing Systems. The tube stoppers contain a substance called thiuram that can sometimes release sulfur-containing gases, which may dissolve into the blood sample and bind the lead particles. This chemical reaction makes it difficult for the Magellan lead tests to detect the correct amount of lead in the sample and may cause falsely lower test results. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. The use of affected product may cause serious adverse health consequences.

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  • Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall

    Wednesday, March 7, 2018

     

    Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed in the recall notice. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Methylprednisolone Sodium Succinate for Injection, USP to the user level due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots. 

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  • Acyclovir 400mg Tablets by Apace Packaging: Recall

    Wednesday, February 21, 2018

    Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg Tablets.

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  • Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall

    Friday, January 12, 2018

    International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel Tablets USP, 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

    Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.

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  • Physio-Control Inc. Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork

    Wednesday, December 20, 2017

    Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest. A delay in therapy could result in serious injury and/or death.

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  • Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings

    Wednesday, December 20, 2017

     FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

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  • Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label

    Monday, December 4, 2017

    During routine inspection of retained AlbuRx 25% samples CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear off portion of the vial label. This is limited to 50 and 100 mL vial sizes. CSL Behring is taking no action with products on the market but is addressing the print settings to ensure readability throughout the shelf life of the product. If the lot number and expiration dating is not able to be verified, customers are asked to contact CSL Customer Support.

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  • The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

    Wednesday, November 29, 2017
    The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.

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