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Philips Respironics has issued a mandatory software correction and update for their Trilogy Evo, EV300, EvoO2, and Evo Universal ventilators due to multiple safety issues. The recall is considered the most serious type and failure to correct the devices may result in serious injury or death. The issues include inaccurate oxygen delivery display, false power loss alarms, volume measurement inaccuracies, and various software errors. Users are advised to update the software and follow the User Manual addendum to prevent adverse health consequences. The company has reported nine injuries and one death related to the affected products. [Extracted from the article]

Smiths Medical has issued a correction for its paraPAC Plus P300 and P310 ventilators due to an issue with the tidal volume knob. The FDA has classified this recall as the most serious type, as the device may cause serious injury or death if used without correction. Users are advised to inspect the ventilators and check if the knob moves or changes position from where it was set. If so, the product should be removed from use until it can be repaired. Smiths Medical has provided instructions for affected customers and can be contacted for further information. [Extracted from the article]

The article discusses a recall of the Phasitron 5 In-Line Valve, a medical device used for Intrapulmonary Percussive Ventilation (IPV) therapy. The recall involves updating the instructions for using the device to prevent accidental misuse of the expiratory port plug. Failure to follow the updated instructions may result in serious injury or death. The recall was initiated due to an increase in reports of patient injuries caused by the failure to remove the blue plug from the expiratory port during therapy. The article provides information on the affected product, actions to be taken by customers, and contact information for inquiries. [Extracted from the article]

Smiths Medical has issued a recall for their paraPAC Plus P300 and P310 Ventilators due to a potential issue with the patient outlet connector. The connector may loosen or detach, which can lead to interrupted therapy, reduced ventilation, and other serious health consequences. Customers are advised to inspect the connector and remove any affected devices from use. Smiths Medical has provided instructions for reporting and repairing the devices. The recall has been classified as the most serious type by the FDA. [Extracted from the article]

Breas Medical has issued an update to the instructions for using the Vivo 45 LS ventilator due to potential elevated formaldehyde levels in newly manufactured devices. This recall is considered the most serious type and may cause serious injury or death if the device is continued to be used. The affected product is the Vivo 45 LS (U.S. version) with specific serial numbers and manufacturing dates. Users are advised to follow the updated instructions, which include operating the device at a maximum room air temperature of 30°C or less and pre-running new devices for at least 14 days. Breas Medical has provided additional actions and recommendations for customers and users. The use of the affected product and exposure to formaldehyde emissions may lead to adverse health consequences, especially in pediatric patients. There have been no reported injuries or deaths related to this issue. The Vivo 45 LS ventilator is used for mechanical ventilation in pediatric patients weighing more than 5kg through adults. Customers in the U.S. with questions about the recall can contact Breas Medical Inc. service. The unique device identifier (UDI) helps identify individual medical devices and allows for more accurate reporting and analysis of adverse events. Adverse reactions or quality problems can be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. [Extracted from the article]

Abbott Diabetes Care Inc has issued a recall for certain FreeStyle Libre 3 sensors due to the risk of inaccurate high glucose readings. The recall does not apply to the FreeStyle Libre 3 reader or app. Users and distributors of the affected sensors are advised to immediately stop using and distributing them, and to dispose of them. The use of the affected product may cause serious adverse health consequences, including severe low blood sugar. Abbott Diabetes Care Inc has provided instructions for customers to request a replacement for the affected sensors. [Extracted from the article]

Baxter Healthcare Corporation has issued a recall for certain components of their Volara System used in lung therapy. The recall is due to a risk of disconnection that may prevent proper ventilation, potentially causing serious injury or death. The affected products include the Volara System Single Patient Use Circuit and Blue Ventilator Adapter Assembly. Customers are advised to stop using the affected products and return them to Baxter. The use of the affected products may lead to adverse health consequences, but no injuries or deaths have been reported. [Extracted from the article]

The article reports that Inari Medical has updated the use instructions for the ClotTriever XL Catheter following serious adverse events, including patient injury and death from device entrapment and pulmonary emboli. Topics include the updated warnings and contraindications for the device, recommendations for handling excessive clot volume, and steps healthcare providers should follow.

Bausch + Lomb/Synergetics Inc. has issued a recall for certain I-Pack Injection Kits due to potential non-sterility. The FDA has classified this recall as the most serious type, as the device may cause serious injury or death if used. The affected products should not be used, and customers are advised to review their inventory, complete a recall acknowledgement form, and notify anyone who may have received the affected product. The recall was initiated because the company could not verify that the products were fully sterilized. The use of the affected product may result in serious adverse health consequences, including eye infections, vision loss, or death. No injuries or deaths have been reported. The Bausch + Lomb/Synergetics Inc. I-Pack Injection Kit is used for intravitreal injection. Customers in the U.S. with questions about the recall should contact their Bausch + Lomb sales representative or the customer service team. [Extracted from the article]

Hamilton Medical has issued a correction for its HAMILTON-C6 Medical Ventilators due to a risk of failed ventilation restart. The recall involves correcting the software of the devices and does not require their removal from use or sale. The FDA has classified this recall as the most serious type, as the device may cause serious injury or death if used without the necessary correction. Hamilton Medical has provided instructions for users to restart the ventilator in case of sensor fail mode during open suction procedures. The affected devices should be updated to software version 1.2.3 as soon as possible. The HAMILTON-C6 Medical Ventilator is used in hospital and healthcare settings to provide mechanical ventilation for pediatric, adult, and neonatal patients. [Extracted from the article]

Baxter has issued a recall for its Life2000 Ventilator due to a potential failure of the battery charging dongle. This recall is considered the most serious type by the FDA, as the device may cause serious injury or death if continued to be used. Users are advised to inspect the battery charger dongle for damage and ensure that the battery is charging appropriately. Baxter has provided instructions for affected customers to obtain a replacement and has urged healthcare professionals to notify patients of the recall. The Life2000 Ventilator is used in both home and healthcare settings to provide mechanical ventilation assistance. [Extracted from the article]

Baxter International Inc. has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly. The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. While no injuries have been reported, if the plug disconnects during therapy, it may lead to an interruption or delay of care. Baxter is working with customers to replace the affected products. The recall applies to specific product codes and was distributed in the United States between August 26, 2022, and December 30, 2023. Customers are advised to visually inspect the nebulizer port prior to therapy and report any adverse events to Baxter or the FDA. [Extracted from the article]

Baxter International Inc. has issued an Urgent Medical Device Recall for Life2000 ventilators due to potential damage to the battery charger dongle. The company has received one serious injury complaint related to this issue and is working with customers to replace affected devices. Damage to the dongle prevents the ventilator's internal battery from charging, which may leave patients unable to use the device and result in oxygen desaturation episodes. Baxter has contacted affected customers and instructed them to inspect the dongle's condition. If damage is observed, patients should contact Baxter for immediate replacement. The recall applies to ventilators distributed in the United States between August 2023 and April 2024. [Extracted from the article]

ZOLL Medical Corporation has issued a recall for 731 ventilators due to missing MRI safety information in the labeling, which may lead to misuse and ventilator failure. The affected products include MRI Compatible 731 ZOLL Ventilators, specifically the AEV, EMV+, and Eagle II models. The updated use instructions emphasize the safe distance requirements between the ventilator and the MRI machine. Users are advised to dispose of old versions of the Operator's Guides and Quick Reference Guides and request replacement manuals. The use of the affected product may result in serious adverse health consequences, including lack of oxygen, difficulty breathing, organ damage, and death. There have been no reported injuries or deaths associated with this issue. [Extracted from the article]

This article discusses a recall of BiPAP V30, BiPAP A30, and BiPAP A40 devices manufactured by Philips Respironics, Inc. The recall involves updating the instructions for using these devices due to interruptions and/or loss of therapy caused by a failure in the Ventilator Inoperative alarm. The FDA has classified this recall as the most serious type, as the device may cause serious injury or death if not used according to the updated instructions. The article provides information on the affected products, what to do if therapy interruptions occur, the reason for the updates to use instructions, and contact information for Philips Respironics, Inc. It also mentions the number of reported injuries and deaths related to the device. [Extracted from the article]

Megadyne has issued a recall for their MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes due to the risk of serious burn injuries to patients. The FDA has classified this recall as the most serious type, as the device may cause serious injury or death if continued to be used. Health care providers and facilities are advised to stop using the electrodes and return them to Megadyne. The recall was initiated after reports of patient burn injuries during procedures where the electrodes were used. Four injuries have been reported, but no deaths. [Extracted from the article]

The FDA has issued a Class I recall for the Optum Nimbus II Plus Ambulatory Infusion System, a medical device used to deliver medications and fluids to patients. The recall is in response to multiple potential failure modes, including battery failure, occlusion, system errors, drug product leakage, and damaged housing. Using the affected pumps could lead to serious injuries or death, such as infection, interruptions in therapy, dehydration, electrolyte imbalance, seizures, shock, and organ failure. Health care providers and patients who use these infusion pumps are advised to take appropriate actions outlined in the recall notification letter. [Extracted from the article]

Draeger, Inc. has issued a recall for their Perseus A500 anesthesia system due to the risk of sudden unexpected shutdown when used on battery power. The FDA has classified this recall as a Class I recall, which is the most serious type of recall. The Perseus A500 anesthesia system is used for anesthetizing adults, children, and neonates during surgical or diagnostic procedures. The recall was initiated after reports of the internal backup battery failing spontaneously, causing the device to shut down without warning. This could result in patients not receiving enough ventilation or oxygen, leading to serious injury or death. Draeger, Inc. has reported four incidents related to this issue, but no injuries or deaths have been reported. Customers are advised to perform a battery test and return any devices that fail the test. For more information, customers can contact Michael A. Kelhart, Director of Quality at Draeger, Inc. [Extracted from the article]

Smiths Medical ASD has issued a recall for their PneuPac paraPAC Plus 300 and 310 Ventilator Kits due to a malfunction that causes non-cycling, continuous positive gas flow, preventing proper ventilation. The FDA has classified this recall as Class I, indicating that the use of these devices may result in serious injuries or death. The affected ventilators are gas-powered emergency and transport portable ventilators used in various medical settings. Smiths Medical has reported 177 adverse events related to this issue, including 8 reports of serious injury. Users of these ventilator kits and healthcare providers are advised to follow specific recommendations provided by Smiths Medical. [Extracted from the article]

Teleflex and Arrow International have issued a Class I recall for their ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits due to increased resistance in the guidewire handle and chamber during use. This issue can lead to serious injuries, including vessel injuries, narrowing, or blockage, and even death. There have been 194 complaints, 10 injuries, and one death reported related to this issue. Medical facilities and distributors are advised to immediately stop using and distributing the affected product and follow the recommended actions outlined in the recall letter. Customers with questions can contact Teleflex and Arrow International Customer Service. [Extracted from the article]

Avanos Medical is recalling certain lots of MIC Gastric-Jejunal Feeding Tube kits due to sterility concerns. The kits include pre-filled syringes supplied by Nurse Assist, which are being recalled separately. The use of these devices may cause serious injuries or death. Health care providers and patients who use these kits should follow the instructions provided by Avanos Medical and report any adverse events immediately. There have been no complaints, injuries, or deaths associated with this issue. [Extracted from the article]

Ventec Life Systems has issued a recall for its VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) due to a manufacturing issue with the bonded spiral wrap. The recall is classified as a Class I recall, indicating that the use of these devices may result in serious injuries or death. The affected breathing package may compromise the structural integrity, functionality, or cause blockage, stoppage, or leaks in the breathing circuit. Pediatric patients who use this device are advised to stop using it and replace it with a non-affected product. Ventec Life Systems can be contacted for further information. [Extracted from the article]

Cardinal Health has issued a recall for their sterile Monoject Luer-Lock and Enteral Syringes due to a change in manufacturing. The FDA has classified this as a Class I recall, which is the most serious type of recall. The affected syringes may cause serious injuries or death if used. Cardinal Health has provided instructions for affected customers to review their inventory, not use the affected products, and contact the company for further assistance. There have been no reports of death related to this recall. [Extracted from the article]

Windstone Medical Packaging, Inc. has issued a recall for their Local Lower Extremity Pack, In House Ocular Pack, and Closure Kit due to concerns over the sterility of the Nurse Assist Sterile Saline included in these kits. The recall is classified as a Class I recall, indicating that the use of these devices may result in serious injuries or death. The affected kits are used in various clinical procedures, such as lower limb procedures, eye-related interventions, and wound closure. The use of the affected kits may lead to adverse health consequences, including infections and vision impairment. Health care providers and individuals who have received care using these kits are advised to check their inventory, quarantine the affected products, and contact Aligned Medical Solutions for further instructions. [Extracted from the article]

Percussionaire has issued a Class I recall for their High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization. The kits are used for continuous ventilation of patients and are intended for use in hospitals or prehospital settings. The defect can lead to serious adverse health consequences, including lung injury, low blood pressure, collapsed lung, cardiac arrest, and death. Percussionaire has sent an Urgent Field Safety Notice to affected customers, requesting the return of affected products. Customers with questions should contact Percussionaire Corporation. [Extracted from the article]

Globus Medical, Inc. has issued a recall for their ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture, which is used in spine surgery. The recall is due to a calibration error that may cause a loss of navigation integrity, potentially resulting in device misplacement and patient harm. There have been two reported injuries, but no deaths. Healthcare providers and individuals undergoing spinal surgery should contact Globus Medical for further instructions. [Extracted from the article]

Fresenius Kabi USA, LLC has issued a Class I recall for their Ivenix Large Volume Pump (LVP) due to mechanical issues with the Fluid Valve Pins. The pump is part of the Ivenix Infusion System used in hospitals and outpatient centers to administer fluids to patients. The recall affects 938 devices distributed in the U.S. between October 2021 and July 2023. The use of affected pumps could result in underdosing, interruption or delay of therapy, and potentially serious harm or death. No injuries or deaths have been reported. Customers are advised to review the list of affected serial numbers, increase monitoring if life-sustaining medications are being delivered, and contact Fresenius Kabi customer support for further assistance. [Extracted from the article]

ROi CPS, LLC has issued a recall for their Regard Operative Lap P&S Surgical Kit due to a potential lack of sterility. The kits were built with a recalled item from Nurse Assist, LLC, which also had a recall due to a lack of sterility. While there have been no reports of injury or death, the use of these kits could potentially result in severe or life-threatening adverse events, especially for patients with weakened immune systems. Health care providers and patients who have used or received these kits are advised to check their inventory, isolate and quarantine affected kits, attach warning labels, and report any adverse health consequences to the FDA. [Extracted from the article]

Megadyne Medical Products, Inc. has issued a recall for their Megadyne Mega Soft Universal Patient Return Electrodes. The recall is a correction, not a product removal, and has been classified as a Class I recall by the FDA, indicating that the use of these devices may cause serious injuries or death. The recall is due to reports of patient burn injuries, including third-degree burns, which may lead to extended hospital stays, scarring, and additional surgeries. The affected devices should only be used on patients aged 12 years and older, and healthcare providers who use these electrodes should follow the updated instructions for use. There have been 99 reported injuries, but no deaths. Customers with questions about the recall should contact the Ethicon Resource Department. [Extracted from the article]