Recalls / Class II
Class IID-0296-2026
Product
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
- Brand name
- Sterile Water
- Generic name
- Water
- Active ingredient
- Water
- Route
- Irrigation
- NDCs
- 0338-0003, 0338-0004
- FDA application
- NDA017866
- Affected lot / code info
- Lot #: G171359, expiry: 05/31/2027
Why it was recalled
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 125,496 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-12-22
- FDA classified
- 2026-01-23
- Posted by FDA
- 2026-02-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0296-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.