Agency classClass IIOur severity:High FDA (Drugs)·D-0301-2015·Announced 2014-12-24

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.

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 3/5 (High).

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
Hazard: sterility
leak
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.

Same brand · CLINIMIX E

Critical
Baxter Recalls Clinimix E Bags Due to Dried Skin Particulate Matter
FDA (Drugs) · 2016-06-01
Severe
Baxter Recalls Clinimix E Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-04-08
Severe
Baxter Recalls Clinimix E IV Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26
Critical
Baxter Recalls Clinimix E Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · sterility