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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter CLEARLINK

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 Class 2 Device Recall Baxter CLEARLINKsee related information
Date Initiated by FirmAugust 29, 2025
Date PostedOctober 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0191-2026
Recall Event ID 97604
510(K)NumberK112893 
Product Classification Stopcock, i.V. Set - Product Code FMG
ProductCLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Code Information UDI/DI 00085412071190, Lot numbers: R25C27086
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
847-9484770
Manufacturer Reason
for Recall		IV sets may leak.
FDA Determined
Cause 2		Process control
ActionBaxter 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.
Quantity in Commerce1440
DistributionUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FMG
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