Tag: Product Recalls

Catheter sterility concerns prompt Class 1 FDA recall for surgery trays

Editor's Note The US Food and Drug Administration has designated DeRoyal Industries’ recall of GeoMed custom tracecarts a class 1, the most serious type of recall indicating a risk of serious injury or death. According to the April 24 FDA notice, the recall is due to sterility concerns with the…

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By: Matt Danford
April 24, 2024
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FDA announces class 1 recalls for premixed embolic, infusion pump software

Editor's Note The US Food and Drug Administration has classified recalls of Boston Scientific’s Obsidio Conformable Embolic and Fresenius Kabi USA’s Ivenix Infusion System Large Volume Pump (LVP) software as class 1, the most serious category and an indicator of risk of serious injury or death. No injuries or deaths…

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By: Matt Danford
April 18, 2024
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FDA warning: unapproved topical analgesics potentially dangerous

Editor's Note The US Food and Drug Administration (FDA) advises consumers to avoid topical analgesics marketed in violation of federal law by six different companies, including: TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9% SeeNext Venture,…

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By: Matt Danford
March 29, 2024
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Universal Recall Platform Alliance centralizes supply disruption communications, calls for members

Editor's Note Medical recall software developer Notisphere is spearheading a collaborative effort among healthcare organizations to address inefficiencies with the recall alert communication process, reduce burdens on providers, speed regulatory compliance achievement by suppliers, and enhance patient safety. As noted in the company’s March 29 announcement, the Universal Recall Platform…

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By: Matt Danford
March 29, 2024
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FDA updates warning about plastic syringes made in China

Editor's Note An ongoing US Food and Drug Administration (FDA) evaluation of plastic syringes made in China reveals that quality problems are more widespread than initially believed, the agency reported on March 19. The update to an original November 23 safety notice recommends the following action to alleviate potential quality…

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By: Matt Danford
March 20, 2024
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Session: Imminent supply chain disruptors—What's your business continuity plan?

Editor's Note “Can cost and resiliency co-exist?” Michael Schiller, CMRP, executive director (interim) of the Association for Healthcare Resources and Materials Management—a professional membership group of the American Hospital Association—asked this session’s audience on the last day of the OR Business Management Conference. “They can co-exist,” he said, “but resiliency…

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By: Tarsilla Moura
February 8, 2024
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Burns prompt recalls of airway scopes, electrosurgical pads

Editor's Note Reports of burn injuries have prompted two medical device recalls: one for Megadyne patient return electrodes and one for Olympus bronchofiberscopes and bronchovideoscopes. According to a December 21 notice from AORN, the former recall is a voluntary correction on the part of Megadyne Medical Products, Inc. Following reports…

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By: Brita Belli
December 21, 2023
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FDA: Class I recall of Ivenix Infusion System

Editor's Note The Food and Drug Administration (FDA), on April 19, identified the recall by Fresenius Kabi USA of its Ivenix Infusion System as Class I, the most serious. The recall was initiated because of a leak in the system that allows fluid to enter the administration set loading area…

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By: Judy Mathias
April 19, 2023
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FDA: Class I recall of Abbott’s glucose monitoring systems

Editor's Note The Food and Drug Administration (FDA), on April 6, identified the recall by Abbott of its FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems as Class I, the most serious. The recall was initiated because the systems’ reader devices, which use rechargeable…

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By: Judy Mathias
April 11, 2023
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FDA: Class I recall of Skippack Medical Lab COVID-19 tests

Editor's Note The Food and Drug Administration (FDA) on February 8 identified the recall by Universal Meditech Inc of its Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) as Class I, the most serious. The recall was initiated because the tests were distributed to US customers without authorization, clearance,…

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By: Judy Mathias
February 14, 2023
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