Agency classClass IIOur severity:Severe FDA (Drugs)·D-1689-2012·Announced 2012-10-03

Baxter Recalls 0.9% Sodium Chloride Injection Due to Chemical Contamination

Baxter Healthcare is recalling 0.9% Sodium Chloride Injection USP in AVIVA containers 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 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls with potential for adverse health consequences (chemical contamination) are rated as Severe (4), as they are not Class I (Critical) but involve a significant risk.

Plain-English summary

Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP packaged in 250 mL and 500 mL AVIVA containers. The recall involves 897,496 containers distributed nationwide and in Puerto Rico. The product is prescription-only and is identified by specific NDC codes and lot numbers listed in the recall notice.

The recall was initiated because the IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). This is a chemical contamination issue. The FDA has classified this recall as Class II, indicating a situation that could cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should check their inventory and records for the affected lot numbers and expiration dates. If the product is found, it should be quarantined and not used. Consumers with questions should contact Baxter Healthcare or their local FDA office.

The recalled product

Product: 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Solution
Hazard: chemical-contamination
Affected units: 897,496

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 (20)

Lot #: a) C840892
C841007
C841403
Exp 09/12
C842377
C842757
C843748
C843946
Exp 10/12
C844332
C845065
C845198
C845347
C846873
C847301
C847608
Exp 11/12
C848481
C848937
C849554

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.

See all →

High
Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
Moderate
Baxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
Moderate
Baxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
Moderate
Baxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
High
Baxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16

Same hazard · chemical contamination