Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1690-2012·Announced 2012-10-03

Baxter Recalls Lactated Ringer's Injection Due to Chemical Contamination

Baxter Healthcare is recalling specific lots of Lactated Ringer's Injection USP due to potential trace levels of cumene hydroperoxide.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a low-risk contamination scenario.

Plain-English summary

Baxter Healthcare Corporation is recalling 55,664 containers of Lactated Ringer's Injection USP. The affected products are packaged in 250 mL and 500 mL AVIVA containers and are distributed nationwide and in Puerto Rico.

The recall is due to chemical contamination. The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

Healthcare providers and patients should check their inventory and discontinue use of the affected lots. The specific lot numbers and expiration dates are: 250 mL containers (C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13) and 500 mL containers (C855445, Exp 09/13; C861492, Exp 12/13).

The recalled product

Product: Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Solutions
Hazard: chemical-contamination
Affected units: 55,664

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 (10)

Lot #: a) C847749
Exp 11/12
C847897
Exp 12/12
C860668
Exp 04/13
b) C855445
Exp 09/13
C861492
Exp 12/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · Baxter Healthcare Corp.

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