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Medical Devices

Updated:

Medline and Centurion Convenience kits - recalled due to lack of sterility, USA

3 weeks ago •source www.fda.gov

Recall notice

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

Medline and Centurion Convenience kits - recalled due to lack of sterility photo #1
303

InfuTronix Nimbus Ambulatory Infusion Pump System recalled due to customer complaints, USA

1 month ago •source www.fda.gov

Recall notice

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

InfuTronix Nimbus Ambulatory Infusion Pump System recalled due to customer complaints photo #1
303

Several Brand CPAP and BIPAP Masks with Magnets - recalled due to interference with medical implants, USA

1 month ago •source www.fda.gov

Recall notice

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

Several Brand CPAP and BIPAP Masks with Magnets - recalled due to interference with medical implants photo #1
303

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

2 months ago •source www.fda.gov

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

Megadyne Electrodes - Alert to Use for ages 12+ only photo #1
303

Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits recalled due to potential lack of sterility, USA

2 months ago •source www.fda.gov

Recall notice

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

Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits recalled due to potential lack of sterility photo #1
303

Covidien and Cardinal Health Urology and room kits and trays Update - recalled due to potential lack of sterility assurance, USA

3 months ago •source www.fda.gov

Recall notice

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

#medicaldevices #recall #us

Covidien and Cardinal Health Urology and room kits and trays Update - recalled due to potential lack of sterility assurance photo #1
303

Aligned Medical Solutions Convenience kits containing saline - recalled due to safety concerns, USA

3 months ago •source www.fda.gov

Recall notice

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

Aligned Medical Solutions Convenience kits containing saline - recalled due to safety concerns photo #1
303

Atrium Express Drains - recalled due to unverified sterility of provided syringes, USA

4 months ago •source www.fda.gov

Recall notice

Getinge / Atrium Medical Corporation notified affected customers of a nationwide recall (medical device correction) for certain Atrium Express Dry Suction Dry Seal Chest Drains in response to a voluntary medical device recall initiated by a supplier, Nurse Assist. On November 8, 2023, Getinge received notice from … See More

#recall #medicaldevices #us

Atrium Express Drains - recalled due to unverified sterility of provided syringes photo #1
303

ResMed Masks with magnets - recalled due to magnetic interference near certain implants and medical devices, USA

4 months ago •source www.fda.gov

Recall notice

ResMed (NYSE: RMD, ASX: RMD) is conducting a voluntary global field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. This voluntary field correction does not require … See More

#recall #medicaldevices #us

ResMed Masks with magnets - recalled due to magnetic interference near certain implants and medical devices photo #1
303

Medline, LP Tracheostomy Care and Cleaning Trays - recalled due to Device & Drug Safety, USA

4 months ago •source www.fda.gov

Recall notice

Medline Industries, LP. announced a voluntary nationwide recall on October 10th, 2023, of several lots and SKUs of Tracheostomy Care and Cleaning Trays. The Tracheostomy Care and Cleaning Trays include a tracheostomy brush as a component that may have sharp edges at the tip that can puncture … See More

#recall #medicaldevices #us

Medline, LP Tracheostomy Care and Cleaning Trays - recalled due to Device & Drug Safety photo #1
303

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