Baxter Healthcare Corporation Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Product Code: 101025, Lot 1000276191, UDI: 37332414007837
Products Sold
Product Code: 101025; Lot 1000276191, UDI: 37332414007837
Baxter Healthcare Corporation is recalling Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodi due to There is a potential leak between the venous patient connector and patient's hemodialysis access.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential leak between the venous patient connector and patient's hemodialysis access.
Recommended Action
Per FDA guidance
An Urgent Medical Device Recall communication will be sent to affected customers via USPS, first class mail. Baxter is asking customers to: 1) Locate and remove all affected product from your facility. 2) Contact Baxter Healthcare Center for Service to arrange for return and credit. 3) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by email.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026