FDA Medical Device Recalls

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.

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.