FDA Medical Device Recalls

B. Braun Medical Inc. Urgent Correction for Hemodialysis Bloodlines

B. Braun Medical Inc. issued an urgent medical device correction for specific hemodialysis bloodlines due to the potential formation of air bubbles. The FDA is issuing an Early Alert to notify the public and advise healthcare providers to use alternate equipment or follow specific mitigation steps if the affected devices must be used.

FDA Early Alert: Handy Solutions Heating Pad Issue

The FDA issued an Early Alert regarding a potentially high-risk issue with Handy Solutions Neck & Shoulders Heating Pads manufactured by Navajo Manufacturing Company. The device can overheat and cause burns or property damage, with four serious injuries reported.

Medline Industries Recalls Electrophysiology and Ultrasound Catheters

Medline Industries is expanding a recall of reprocessed electrophysiology and ultrasound catheters due to potential residual particulates. The FDA has classified this as the most serious type of recall, as the devices could cause serious injury or death. Affected customers are instructed to return or destroy the product.

FDA Identifies Infusion Pump Software Correction as Most Serious Recall

The FDA has identified a software correction for the Fresenius Kabi Ivenix Large Volume Pump as its most serious type of recall, indicating a potential risk of serious injury or death. Affected healthcare providers are urged to update the pump software to version 5.10.2 as soon as possible and implement temporary risk mitigation measures.