FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter Solution Set with Duo-Vent Spike, REF 2R8404
- Recall number
- Z-1009-2025
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter Solution Set with Duo-Vent Spike, REF 2R8404
- Status
- Open, Classified
- Initiated
- 2024-12-20
- Posted
- 2025-01-22
- Terminated
- not on file
- Reason
- Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- 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
- Quantity
- not on file
- Distribution
- US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.
- Lot, serial or model codes
- UDI/DI 00085412676630, Lot Numbers: DR24C22079 (exp.3/247/2026), DR24H23086 (exp. 8/26/2026)
- 510(k) numbers
- ["K180739"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28