Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling 139,104 bags of 0.9% Sodium Chloride Injection due to a reported complaint of mold on the interior surface of the overpouch.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this context, a sterility failure of an intravenous product which poses a significant risk of harm, align with the 'Severe' criteria (Score 4), as it is not a Class I recall but involves a serious potential hazard.
Plain-English summary
Baxter Healthcare Corporation is recalling 139,104 bags of 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container. The product is identified by NDC 0338-0049-38, Lot # P329821, and an expiration date of 08/31/2016.
The recall was initiated because the firm reported a complaint regarding mold on the interior surface of the overpouch, which raises a lack of assurance of sterility. The affected product was distributed nationwide and in Puerto Rico.
Healthcare providers and patients should stop using 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 Corporation
- Category
- Drug — Intravenous Solution
- Affected units
- 139,104
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 #: P329821
- Exp 08/31/2016
Distribution
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