Sterile Water for Irrigation Recalled Due to Plastic Particle Contamination
Baxter Healthcare Corporation is recalling 125,496 units of Sterile Water for Irrigation because plastic particles from the bottle rim have been observed floating into the solution. The nationwide recall affects lot number G171359.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves observed contamination of a sterile medical product with plastic particles. Although no illnesses or injuries have been reported, the hazard is a realized defect in a sterile product intended for medical use, creating a risk of harm during irrigation procedures.
Plain-English summary
Baxter Healthcare Corporation has recalled 125,496 units of Sterile Water for Irrigation because plastic particles from the bottle rim have been observed floating into the solution.
The affected product is Sterile Water for Irrigation in 250 mL single-dose plastic bottles, NDC 0338-0004-02, produced by Baxter Healthcare Corporation in Deerfield, Illinois. The specific lot number is G171359 with an expiration date of May 31, 2027. This product is distributed nationwide.
Sterile Water for Irrigation is a prescription medication used for medical irrigation procedures. Contamination with plastic particles could pose a risk during medical use. The FDA classified this as a Class II recall.
Consumers, healthcare providers, and facilities should discontinue use of the affected lot and contact Baxter Healthcare Corporation or the FDA for guidance on product return or replacement.
The recalled product
- Product
- STERILE WATER (WATER)
- Brand
- STERILE WATER
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Irrigation Solution
- Hazard
- plastic-particles
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: G171359
- expiry: 05/31/2027
Distribution
Distributed nationwide across the United States.
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