—#211547

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K180739
Affected lot / code info: UDI/DI 00085412676630, Lot Numbers: DR24C22079 (exp.3/247/2026), DR24H23086 (exp. 8/26/2026)

Why it was recalled

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.

Timeline

Recall initiated: 2024-12-20
Posted by FDA: 2025-01-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211547. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.