Baxter Recalls Clinimix E IV Bags Due to Sterility Concerns
Baxter Healthcare is recalling 7,220 bags of Clinimix E IV solution because leaks were observed, raising concerns about sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves an intravenous drug with a sterility defect (leaks), which poses a risk of infection or harm, but no illnesses or injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corp. is recalling 7,220 bags of Clinimix E (4.25/10 sulfite-free) Injections. The product is an intravenous solution containing amino acids, electrolytes, and dextrose, packaged in a CLARITY Dual Chamber Container. The specific lot affected is P311357, with an expiration date of 12/31/2015, and the product was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. Leaks were observed from the bag seam and port seal, which could compromise the sterile integrity of the intravenous solution. No illnesses or injuries have been reported in the source text.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number P311357 and NDC 0338-1115-04. If the product is found, it should be returned to the distributor or disposed of according to local regulations for medical waste.
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 — Intravenous Solution
- Affected units
- 7,220
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)
- Product Code 2B7717 Lot # P311357
- exp 12/31/2015
Distribution
Distributed nationwide across the United States.
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