Baxter Recalls Sodium Chloride Irrigation Due to Insect Particulate Matter
Baxter Healthcare is recalling 0.9% Sodium Chloride Irrigation bottles due to a product complaint identifying an insect as particulate matter.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (foreign object in irrigation fluid) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 257,364 bottles of 0.9% Sodium Chloride Irrigation, USP, 500 mL. The recall was initiated following a product complaint that identified the presence of particulate matter, specifically an insect, in the product.
The affected product is identified by Lot # G120162 with an expiration date of 11/18. The product was distributed nationwide and in Puerto Rico. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and consumers should discontinue use of the affected product and contact Baxter Healthcare Corporation for further instructions or a replacement.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Irrigation
- Affected units
- 257,364
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 # G120162
- Exp 11/18
Distribution
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