Data Foundry

Medical device recalls 2025

Baster Continu-Flo Solution Set — Class II medical device recall Z-2594-2025

Ongoing recall by Baxter Healthcare Corporation, reported 2025-10-01, distributed nationwide. Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution s

Recall numberZ-2594-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2025-08-08
Classified2025-09-19
Reported by FDA2025-10-01
DistributedNationwide (US)
Quantity14,400 units
UPC / GTIN / UDI-DI00085412048994
Lot numbersR24I20079
Model numbers2C8519
Expiration dates2026-09-21

Product

Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set

Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

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-2594-2025. 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.