Baxter Recalls 0.9% Sodium Chloride Irrigation Due to Nylon Fibers
Baxter Healthcare Corp. is recalling 211,752 bottles of 0.9% Sodium Chloride Irrigation, USP, 1000 mL, due to the presence of nylon fibers.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter (nylon fibers) in an irrigation solution, which fits the criteria for moderate risk without reported serious injuries.
Plain-English summary
Baxter Healthcare Corp. is recalling 211,752 bottles of 0.9% Sodium Chloride Irrigation, USP, 1000 mL, Not for Injection. The product is identified by NDC 0338-0048-04, Lot # Gl09272, and an expiration date of 09/16.
The recall was initiated because nylon fibers were found in a bottle of the irrigation solution. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact Baxter Healthcare Corp. for further instructions or a refund.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Irrigation Solution
- Affected units
- 211,752
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 # Gl09272
- Exp 09/16
Distribution
Distributed nationwide across the United States.
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