Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling 282,080 bags of 0.9% Sodium Chloride Injection USP due to a lack of assurance of sterility caused by potential container leaks.
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, an FDA Class II recall involving a risk of harm (loss of sterility in an IV product) without explicitly reported fatalities or hospitalizations falls under the 'Severe' category (Score 4), as it is not a Class I recall but involves a significant potential for serious injury.
Plain-English summary
Baxter Healthcare Corporation is recalling 282,080 bags of 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags. The product is identified by Lot # P337857 with an expiration date of 07/31/16. The recall was initiated because of a lack of assurance of sterility, specifically due to the potential for leaking containers.
The affected product was distributed nationwide and in Puerto Rico. This is a prescription-only medication intended for intravenous use. The recall is classified as Class II by the FDA.
Healthcare providers and consumers should stop using the affected product and contact Baxter Healthcare Corporation for further instructions or to arrange for a return.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
- Affected units
- 282,080
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 #: P337857
- Exp 07/31/16
Distribution
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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