Z-0204-2026Class II

CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m)

Name: Z-0204-2026 CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m)
Creator: Baxter Healthcare Corporation
Published: 2025-08-29
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-08-29 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519 on 2025-08-29. FDA classified it as Class II and gives the reason as "IV sets may leak". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0204-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-29
Posted: 2025-10-16
Recalling firm: Baxter Healthcare Corporation
Product: CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Product code: FMG Stopcock, I.V. Set
Reason for recall: IV sets may leak.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 18720 units
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.
Product codes and lots: UID/DI 00085412625553, Lot numbers: R25C08147

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0204-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0189-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0190-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0191-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0192-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0193-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0194-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0195-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0196-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0197-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0198-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0199-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0200-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0201-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0202-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0203-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0204-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16

Product code FMG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)