Agency classClass IIOur severity:Severe FDA (Drugs)·D-0428-2015·Announced 2015-04-08

Baxter Recalls Clinimix E Due to Sterility Assurance Concerns

Baxter Healthcare is recalling 7,444 containers of Clinimix E 5/20 due to a lack of assurance of sterility and increased leak complaints.

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 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage risks, specifically involving a lack of sterility assurance in an intravenous product.

Plain-English summary

Baxter Healthcare Corporation is recalling 7,444 containers of Clinimix E 5/20 sulfite-free Injection, 2000 mL in Dual Chamber Container. The product is a prescription-only intravenous solution containing amino acids, electrolytes, and dextrose. The recall is being conducted due to a lack of assurance of sterility and an increase in complaints regarding leaks.

The affected product is identified by Product code 2B7722, Lot number P306365, and an expiration date of 8/31/2015. The distribution pattern for this recall includes nationwide distribution in the United States and Singapore.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

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: 7,444

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 (3)

Product code: 2B7722
Lot#: P306365
exp date: 8/31/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same brand · CLINIMIX E

Critical
Baxter Recalls Clinimix E Bags Due to Dried Skin Particulate Matter
FDA (Drugs) · 2016-06-01
High
Baxter Recalls Clinimix E IV Bags Due to Sterility Concerns
FDA (Drugs) · 2014-12-24
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