Baxter Healthcare Corporation: Medical Device Recall in 2025 - (Recall #: Z-0189-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255

Product Classification:

Class II

Date Initiated: August 29, 2025

Date Posted: October 22, 2025

Recall Number: Z-0189-2026

Event ID: 97604

Reason for Recall:

IV sets may leak.

Status: Ongoing

Product Quantity: 49200

Code Information:

UDI/DI 00085412046310, Lot numbers: R25C26161 and R25D01031

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated