This follows reports of unwanted particulate matter found in the sterile tubing of the inlets, which are used in hospital and clinic pharmacies to prepare drugs for intravenous administration.
Although no injuries have been reported, the recall is considered serious due to the potential for life-threatening complications if contaminated inlets are used. The ExactaMix systems themselves remain safe, with the issue confined to specific lots of disposable inlets.
Baxter and the FDA have advised pharmacists and clinical staff to inspect all parts of the recalled inlets—including packaging, tubing, connectors, and spikes—for any foreign particles before use. If any contamination is detected, the inlets should be discarded, and Baxter will provide replacements. If no particulate matter is found, the inlets can continue to be used safely.
The FDA has asked healthcare providers to share the recall notice widely to ensure patient safety, while Baxter has already alerted affected customers