Affected Product
The FDA is aware that Baxter Healthcare Corporation has issued a letter to affected healthcare providers recommending certain lots of Solution Sets with Duo-Vent Spikes be removed from use related to a potentially high-risk device issue. See this page for affected products.
What to Do
- On December 20, 2024, Baxter sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
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- Immediately check your stock for the affected product and lot numbers listed above and do not use. The product code and lot number can be found on the individual product and shipping carton.
- Check this web page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.