Sterile water for irrigation recalled over plastic particles from bottle rims
Baxter Healthcare is recalling 125,496 bottles of Sterile Water for Irrigation, 250 mL, after plastic particles from the bottle rim were observed floating in the solution.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: visible plastic particulate in a sterile irrigation solution is a contamination hazard, and no injuries are reported.
Plain-English summary
Sterile Water for Irrigation, 250 mL, in a single-dose plastic bottle, Rx only, under NDC 0338-0004-02, is being recalled by Baxter Healthcare Corporation of Deerfield, Illinois.
The reason given in the enforcement record is the presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution.
The record lists 125,496 bottles from lot G171359, expiry 05/31/2027. Distribution was nationwide. The FDA has classified the action as Class II.
Particulate matter in a sterile irrigation solution can be introduced to the site being irrigated. The record reports no injuries. Facilities should quarantine the affected lot and follow Baxter's instructions.
The recalled product
- Product
- STERILE WATER (WATER)
- Brand
- STERILE WATER
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Irrigation solution
- Affected units
- 125,496
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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