CLEARLINK Extension Set (Baxter) – IV Set Leak (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
UDI/DI 00085412048963, Lot numbers: R25C31024
Products Sold
UDI/DI 00085412048963, Lot numbers: R25C31024
Baxter Healthcare Corporation is recalling CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activate due to IV sets may leak.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IV sets may leak.
Recommended Action
Per FDA guidance
Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 8/29/2025 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of the affected product. The product codes and lot numbers can be found on the individual product package and shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and replacement at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. 4. If you purchased this product from a distributor or wholesaler, please contact your supplier to arrange for return of the affected product. Please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 5. Please forward a copy of this communication to the medical director, purchasing director, and any other departments within your institution who use the affected product. 6. If you are a wholesaler, distributor/reseller, or OEM that distributed any affected product, please conduct a user-level recall of the affected product and check the associated box on the customer portal. For questions, please contact Baxter Healthcare Center for Service at 888-229-0001, 7:00 am and 6:00 pm Central, M-F.
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