FDA Medical devices recall ·
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m)… recall
- Recall number
- Z-0204-2026
- Date
- (initiated August 29, 2025)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18720 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Why was it recalled?
IV sets may leak.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UID/DI 00085412625553, Lot numbers: R25C08147
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0204-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.