Baxter Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter
Baxter Healthcare is recalling 4,200 containers of 0.9% Sodium Chloride Injection because blue polyisoprene shavings were found inside the bag port tubes.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which corresponds to the 'Critical' severity score in the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling 4,200 containers of 0.9% Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container. The affected product is identified by Lot C931923 with an expiration date of 8/31/2015. The recall was initiated due to the presence of particulate matter, specifically blue polyisoprene shavings found inside the bag port tubes.
The affected product was distributed nationwide. The FDA has classified this recall as Class I, which is the most serious classification for drug recalls.
Consumers and healthcare providers should stop using the affected product immediately and contact Baxter Healthcare Corporation for further instructions or a refund.
The recalled product
- Product
- 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Fluids
- Affected units
- 4,200
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 C931923
- exp 8/31/2015
Distribution
Distributed nationwide across the United States.
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