Baxter Recalls Clinimix IV Bags Due to Particulate Matter
Baxter Healthcare is recalling 7,388 bags of Clinimix 5/15 sulfite-free IV solution because they contain particulate matter, including wood, sodium citrate, and dextrose.
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 agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
Baxter Healthcare Corporation is recalling 7,388 bags of Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bags. The affected product is identified by Lot# P285122 and has an expiration date of 5/2014. The NDC for the specific recalled item is 0338-1099-04.
The recall was initiated due to the presence of particulate matter in the solution. The identified particulates include wood, sodium citrate, and dextrose. This product is a prescription-only intravenous solution distributed nationwide in the United States.
Healthcare providers and patients should stop using the affected bags immediately. Baxter Healthcare is the recalling firm and is responsible for managing the recall of these specific lots.
The recalled product
- Product
- CLINIMIX (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE)
- Brand
- CLINIMIX
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
- Affected units
- 7,388
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# P285122
- Exp 5/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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