Z-1009-2025Class II

Baxter Solution Set with Duo-Vent Spike, REF 2R8404

Name: Z-1009-2025 Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Creator: Baxter Healthcare Corporation
Published: 2024-12-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-12-20 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter Solution Set with Duo-Vent Spike, REF 2R8404 on 2024-12-20. FDA classified it as Class II and gives the reason as "Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable". 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-1009-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-20
Posted: 2025-01-22
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Product code: FPA Set, Administration, Intravascular
Reason for recall: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/20/2024. The notice explained the problem with the device, hazard involved and requested the following: 1. Immediately locate, isolate, and cease all use of the affected lot number of the product. The product code and lot number can be found on the individual product and shipping carton. 2. Contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday to arrange for return and credit. 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, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. 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 the supplier according to their instructions. 5. Please forward a copy of this communication to the Medical Director/Office Manager, Director of Pharmacy, Medication Safety Officer, Purchasing Director/Head of central supply and any other departments within your institution who use the affected product. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this co
Distribution: US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.
Product codes and lots: UDI/DI 00085412676630, Lot Numbers: DR24C22079 (exp.3/247/2026), DR24H23086 (exp. 8/26/2026)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1009-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1009-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-22
Z-1010-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-22
Z-1011-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-22

Product code FPA

K180739Class IIClearlink System Solution SetBaxter Healthcare Corporation / cleared 2019-05-28

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)