Baxter Recalls Clinimix E IV Bags Due to Particulate Matter
Baxter Healthcare is recalling 7,068 bags of Clinimix E 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 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 agency classified this as an FDA Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of foreign particulate matter (wood) in an intravenous solution is a significant hazard.
Plain-English summary
Baxter Healthcare Corporation is recalling 7,068 bags of Clinimix E 4.25/10 sulfite-free Injection, 2000 mL CLARITY Dual Chamber Container bags. The product is a prescription-only intravenous solution containing amino acids, electrolytes, and dextrose. The specific lot affected is P275883, with an expiration date of 10/2013.
The recall was initiated due to the presence of particulate matter in the solution. The identified particulates include wood, sodium citrate, and dextrose. This defect poses a risk to patients receiving the intravenous infusion.
The affected product was distributed nationwide in the United States. Clinicians and patients should stop using the recalled lot and contact Baxter Healthcare or their local FDA office for further instructions. Patients should consult their healthcare provider if they have already received the affected product.
The recalled product
- Product
- CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
- Brand
- CLINIMIX E
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
- Affected units
- 7,068
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#: P275883
- Exp 10/2013
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.
See all 3 products in this recall →Related recalls
Same brand · CLINIMIX E
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