Baxter Recalls Sodium Chloride Injection Due to Sterility Assurance Issues
Baxter Healthcare is recalling 196,128 containers of 0.9% Sodium Chloride Injection due to lack of sterility assurance and leak complaints.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves a lack of sterility assurance for an intravenous product, which poses a risk of serious adverse health consequences such as infection, fitting the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.
Plain-English summary
Baxter Healthcare Corporation is recalling 196,128 containers of 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack. The affected product is identified by Product code 2B1308, Lot number P316497, and an expiration date of 10/2015. The recall was initiated due to a lack of assurance of sterility and an increase in complaints regarding leaks.
The product was distributed nationwide and in Singapore. This is a prescription-only intravenous medication. 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 patients should stop using the affected product and contact Baxter Healthcare or their local FDA office for further instructions. Consumers should not use the product if they have received it for personal use, though this is primarily a hospital and institutional product.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp
- Category
- Drug — IV Fluids
- Affected units
- 196,128
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 (3)
- Product code: 2B1308
- Lot#: P316497
- exp date: 10/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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