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HSAG ESRD Alerts, Recalls, and Notices

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  • Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error

    Friday, November 13, 2020
    Cook Medical is recalling the fixed core wire guides because five lots of wire guides dropped onto an unchecked surface during production. This drop could cause the wire guide to bend out of shape or become dirty.

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  • Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

    Tuesday, November 10, 2020
    Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who...

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  • Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2

    Tuesday, November 3, 2020
    The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. Generally,...

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  • Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets

    Tuesday, November 3, 2020
    Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as...

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  • Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets

    Tuesday, November 3, 2020
    Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit...

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  • Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse

    Monday, November 2, 2020
    Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.

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  • Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps

    Monday, November 2, 2020
    Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods...

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  • Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing

    Wednesday, October 14, 2020
    The U.S. Food and Drug Administration (FDA) recommends that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an...

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  • Hurricane Delta—Clinical Guidance for Carbon Monoxide (CO) Poisoning

    Sunday, October 11, 2020
    The Centers for Disease Control and Prevention (CDC) is reminding healthcare professionals seeing patients from the areas affected by Hurricane Delta to maintain a high index of suspicion for carbon monoxide (CO) poisoning. Other people who may be exposed to the same CO source may need to be...

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  • Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets

    Tuesday, October 6, 2020
    Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA)...

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