Recall Z-0193-2026
Baxter Healthcare Corporation · initiated August 29, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
Codes / lots: UDI/DI 00085412048970, Lot numbers: R25A13055, R25B24024, R25B25154, R25C05017, R25C13147, R25C18017, R25C18024, R25C25116, R25C26093, R25C31079, R25D03055, R25D12123, R25D19024
Reason for recall
IV sets may leak.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0193-2026
- Initiated
- August 29, 2025
- Posted by FDA
- October 16, 2025
- Product code
- FMG – Stopcock, I.V. Set
- Quantity
- 958351
- Distribution
- US 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0189-2026 Class II | CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0190-2026 Class II | CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0191-2026 Class II | CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0192-2026 Class II | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0194-2026 Class II | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0195-2026 Class II | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0196-2026 Class II | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0197-2026 Class II | CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0198-2026 Class II | CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0199-2026 Class II | CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0200-2026 Class II | CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0201-2026 Class II | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0202-2026 Class II | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0203-2026 Class II | CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK…IV sets may leak. | 08/29/2025Open, Classified |
| Z-0204-2026 Class II | CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519IV sets may leak. | 08/29/2025Open, Classified |