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  • Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

    Wednesday, August 14, 2019

    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

    Recalled Product

    • Volumat MC Agilia Infusion System and Vigilant Drug Library
    • Models
      • Volumat MC Agilia Z021135, Software Versions 1.7 and 1.9a
      • Vigilant Drug Library Z073476, Software Versions 1.0 and 1.1
    • Lot Numbers: All
    • Manufacturing Dates: All
    • Distribution Dates: All
    • Devices Recalled in the U.S.:
      • Volumat MC Agilia - 9,461
      • Vigilant Drug Library - 83
    • Date Initiated by Firm: June 21, 2019

    Reason for Recall
    When enabled, the "Keep Vein Open (KVO), End of Infusion" alarm triggers when the infusion is complete. This results in the therapeutic rate of a medication changing to a non-therapeutic rate, as defined by the KVO rate. KVO alarms should be high priority. If a health care provider fails to respond to a "KVO, End of Infusion" alarm for a critical medication, a delay in care and/or under-infusion of medication can take place, which may lead to death or serious injury because the patient will be receiving a non-therapeutic rate of medication.

    Fresenius Kabi will change their  "Keep Vein Open (KVO), End of Infusion" alarm from a "low priority" to a "high priority" alarm to ensure the health care provider knows the infusion has completed.  There has been one death reported outside of the United States related to a norepinephrine infusion where a health care provider did not adjust the "Volume to be Infused" after changing the drug bag and then did not notice the pump's "low priority" "KVO, End of Infusion" alarm. No other injuries have been reported in the rest of the world or in the United States.

    Fresenius has also identified four software errors occurring with both the Volumat MC Agilia Infusion System and Vigilant Drug Library that may cause over-infusion or under-infusion of fluids/medications. These software errors could cause serious patient harm or death. There have been zero injuries and 14 complaints reported related to these software errors.  

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  • Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators

    Monday, August 12, 2019

    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

    Recalled Product

    • Certain Ellipse Implantable Cardioverter Defibrillators
    • Lot Numbers: All lots manufactured between April 5, 2019 - May 29, 2019
    • Model Numbers: CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, CD2411-36Q
    • Manufacturing Dates: April 5, 2019 to May 29, 2019
    • Distribution Dates: May 6, 2019 to June 14, 2019 
    • Devices Recalled in the U.S.: 108
    • Date Initiated by Firm: June 20, 2019

     

    Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor.  The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure.

    Abbott is aware of zero (0) related reports of this failure occurring in any affected implanted devices.  Of the devices recalled in the US, 31 devices have been implanted. The complaints and MDRs available have either reported that the affected devices have been replaced or are scheduled to be replaced with another ICD generator. None of the complaints or MDRs indicate that any patient harm or adverse events have occurred, and no deaths have been reported.

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  • COVIDIEN LLC Issues Voluntary Recall

    Saturday, July 20, 2019

    COVIDIEN LLC issues voluntary recall of MAHURKAR and Argyle acute hemodialysis catheters.

    Product Description:

    MAHURKAR and Argyle acute hemodialysis catheters, Material numbers:

    8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011 8817277021 8817277027 8830414001 8830414002 8830415001 8830415003 8830416001 8830416003 8830416021 8830416023 8831173010 8831173011 8831173012 8831661001 8831662001 8831663001 8831663002 8831663021 8831663022 8832539001 8832539002 8832539003 8832539006 8832539007 8888115132 8888115133 8888115162 8888115163 8888115192 8888115193 8888115242 8888115243 8888135131 8888135132 8888135133 8888135134 8888135135 8888135136 8888135137 8888135138 8888135139 8888135140 8888135141 8888135142 8888135161 8888135162 8888135163 8888135164 8888135165 8888135166 8888135167 8888135168 8888135191 8888135192 8888135193 8888135194 8888135195 8888135196 8888135197 8888135198 8888135241 8888135242 8888135243 8888135244 8888135245 8888135246 8888135247 8888135248 8888340629 8888340637 8888345504 8888345512 8888345520 8888345538 8888345603 8888345611 8888345629 8888345637 8888101001HP 8888101002HP 8888101003HP 8888101004HP 8888102003HP 8888102004HP 8888103001HP 8888103002HP 8888103003HP 8888103004HP 8888104003HP 8888104004HP 8888340629HP 8888340637HP 8888345504HP 8888345512HP 8888345520HP 8888345538HP 8888345603HP 8888345611HP 8888345629HP 8888345637HP

    Reason for Recall:
    The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

    Product Quantity:
    2,223,067

    Recall Number:
    Z-1955-2019

    Code Information:
    All lots

    Classification:
    Class II

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  • Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100

    Saturday, July 20, 2019

    The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

    Recalled Product

    Alaris Pump Model 8100 Infusion Sets

    • Lot Numbers: See full list of affected devices in BD recall notice
    • Manufacturing Dates: May 1, 2016 to March 31, 2019
    • Distribution Dates: July 1, 2016 to April 18, 2019
    • Devices Recalled in the U.S.: 151,139,816
    • Date Initiated by Firm: May 6, 2019

    Device Use

    Becton Dickinson (BD) Alaris Infusion Sets are used with an infusion pump to deliver fluids including medications, blood, or blood products, into a patient's body in a controlled manner. The pump administers fluid via an infusion tubing set into a patient's vein or through other cleared routes of administration. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male Luer with spin lock, and tubing of different lengths. These infusion sets are intended to be used with the BD Alaris Pump Module 8100. The devices are used in hospitals and other health care facilities.

    Reason for Recall

    Becton Dickinson (BD) is recalling Alaris Infusion Sets, due to the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a "running status." The firm has determined that the silicone segment of the affected administration set has non-uniform thickness. Non-uniform wall thickness can lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing. This device defect may cause serious adverse health consequences for patients, including death. This recall has been associated with MDR reports, several of which are associated with serious injuries.

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  • Voluntary Recall: BAxter REVACLEAR 400 Dialyzer

    Monday, July 8, 2019

    The FDA has announced a Class II recall of three lots of the Baxter Revaclear 400 Dialyzer, Product Code 114746L.

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  • Voluntary Recall: Baxter REVACLEAR 300 Dialyzer

    Monday, July 8, 2019

    The FDA has announced a Class II recall of 59 lots of the Baxter Revaclear 300 Dialyzer, Product Code 114745L. These HD dialyzers may leak blood during dialysis because there is potential for fibers in the dialyzer to rupture.

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  • Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication

    Monday, July 1, 2019

    The FDA is warning patients and health care providers that certain Medtronic MiniMed™ insulin pumps have potential cybersecurity risks. Patients with diabetes using these models should switch their insulin pump to models that are better equipped to protect against these potential risks.

    Medtronic is recalling the following affected MiniMed pumps and providing alternative insulin pumps to patients.

    Pump Model                                                 Software Version
    MiniMed™ 508                                                  All versions
    MiniMed™ Paradigm™ 511                              All versions
    MiniMed™ Paradigm™ 512/712                       All versions
    MiniMed™ Paradigm™ 515/715                       All versions
    MiniMed™ Paradigm™ 522/722                       All versions
    MiniMed™ Paradigm™ 522K/722K                  All versions
    MiniMed™ Paradigm™ 523/723                       Version 2.4A or lower
    MiniMed™ Paradigm™ 523K/723K                  Version 2.4A or lower
    MiniMed™ Paradigm™ 712E*                          All versions
    MiniMed™ Paradigm™ Veo 554CM/754CM*   Version 2.7A or lower
    MiniMed™ Paradigm™ Veo 554/754*              Version 2.6A or lower

    * Available outside the United States only.

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  • Macleod's Pharmaceutical Issues Voluntary Recall

    Thursday, June 27, 2019

    Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots  of  50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration's interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.

    Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets, USP should continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

    To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

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  • Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium

    Thursday, June 13, 2019

    Teva Pharmaceuticals USA, Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets. This expanded recall includes six (6) lots of bulk losartan potassium USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength) due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the six (6) bulk lots of these drug products. Based on the available information, there is a potential risk of developing cancer in a few patients following long-term use of products containing high levels of NMBA.

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  • Heritage Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Amikacin Sulfate Injection

    Monday, June 10, 2019

    Heritage Pharmaceuticals Inc. (“Heritage”) East Brunswick, New Jersey, is initiating a voluntary recall of Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), Lot: VEAC025, Expiry Date: October 2019 and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), Lot: VPCA172, Expiry Date: April 2020, to the consumer level. These drug products are manufactured by Emcure Pharmaceuticals Ltd. (“Emcure”) and distributed by Heritage. The voluntary recall is being initiated due to microbial growth having been detected in one unreleased sublot of Lot VPCA172 and one unreleased sublot Lot VEAC025, which may indicate a lack of sterility in the other sublots.

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