Baxter alerts providers to potential high-risk issues with devices
The Food and Drug Administration Dec. 31 released an alert highlighting a Baxter letter that recommended health care providers not use certain lots of Solution Sets with Duo-Vent Spikes due to a potentially high-risk issue. Baxter reported that some affected products were incorrectly assembled with inverted slide clamps.
The affected products include:
• Solution Set with Duo-Vent Spike, lot DR24C22079, expiration March 24, 2026, and lot DR24H23086, expiration Aug. 26, 2026.
• Clearlink System Solution Set with Duo-Vent Spike, lot DR24C15109, expiration March 16, 2026.
• Continu-Flo Solution Set with Duo-Vent Spike, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, lot DR24B21017, expiration Feb. 28, 2026.
Related News Articles
Headline
The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus…
Headline
The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products. The agency said Abiomed found its Impella…
Headline
Olympus has expanded a voluntary recall of its ViziShot 2 FLEX Needles due to complaints of device components ejecting or attaching during…
Headline
The Food and Drug Administration has identified a recall by Cook Medical of Zenith Alpha 2 Thoracic Endovascular Graft proximal components after Cook Medical…
Headline
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
Headline
The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil SpeedControl Dials used with the SmartDrive MX2+ Power Assist Device…