Data Foundry

Medical device recalls 2025

Baxter Solution Set with Duo-Vent Spike — Class II medical device recall Z-1009-2025

Ongoing recall by Baxter Healthcare Corporation, reported 2025-01-29, distributed nationwide. Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tub

Recall numberZ-1009-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2024-12-20
Classified2025-01-22
Reported by FDA2025-01-29
DistributedNationwide (US)
UPC / GTIN / UDI-DI00085412676630
Lot numbersDR24C22079
Model numbers2R8404
Expiration dates2026-08-26

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1009-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.