CLASS II ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report
Baster Continu-Flo Solution Set, Non-Vented recalled
Baxter Healthcare is recalling Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck, distributed nationwide in the US. The recall was initiated on 8 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2594-2025
- FDA event ID
- 97447
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Aug 2025
- FDA classified
- 19 Sep 2025
- Reported
- 1 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 8 Aug 2025 | Recall initiated by company | |
| 19 Sep 2025 | Classified by FDA | +42 days |
| 1 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 00085412048994, Lot Number R24I20079, Exp. 9/21/2026
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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