Here are some of the latest recalls reported to the FDA:
Olympus has recalled certain single-se guide sheath kits due to the risk of the radiopaque guide sheath tip detaching during procedures. If the tip detaches, it could cause serious adverse health consequences, including bleeding and death. Healthcare providers have been advised to discontinue the use of affected devices immediately and return them to Olympus. There have been 26 reported injuries and no deaths.
Getinge has expanded its previous recall of the vaporizer sevoflurane Quick-Fil due to reports of discoloration and corrosion within the devices, which may lead to the formation of hydrogen fluoride, a toxic and hazardous acid that can harm both patients and healthcare professionals. Affected users are advised to stop using the vaporizers and follow Getinge’s recall instructions. There have been no reported injuries or deaths.
Fresenius Kabi USA has issued a correction for software versions 5.9.2 and earlier of the IVenix infusion system due to software anomalies that could lead to over infusion or under infusion of medication. These failures could result in serious patient harm including arrhythmias, hypertension, sedation issues or clotting changes. Users were advised to update the software to version 5.10 immediately to prevent potential harm. There have been no reported injuries or deaths.
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