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Safety Reports: Medical Devices

Updated:

Baxter International Inc. announced today it has issued an Urgent Medical Device Recall for Life2000 ventilators with an attached battery charger dongle. The recall is due to reports that the devices are not properly charging when there is damage to the battery charger dongle. The impacted ventilators… See more

#recall #medicaldevices #us

Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability… See more

#recall #medicaldevices #us

MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on the reports… See more

#recall #medicaldevices #us

In direct response to the Nurse Assist, LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a nationwide recall on November 15, 2023, for its Medline and Centurion branded convenience kits containing Nurse Assist 0.9% Sodium… See more

#recall #medicaldevices #us

InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the… See more

#medicaldevices #us

On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or… See more

#medicaldevices #us

Megadyne Electrodes - Alert to Use for ages 12+ only, USA

4 months ago source fda.gov details

Recall notice

Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA… See more

#recall #medicaldevices #us

Avanos Medical, Inc. voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon of the feeding tube. This recall initiated in direct response to… See more

#recall #medicaldevices #us

Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and… See more

#recall #medicaldevices #us

Aligned Medical Solutions, initiated a nationwide recall of Convenience kits containing saline because the Product cannot be verified as having the required sterility assurance level. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Aligned Medical Solutions distributed these kits… See more

#recall #medicaldevices #us

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