Agency classClass IOur severity:Critical FDA (Drugs)·D-1208-2015·Announced 2015-07-15

Baxter Recalls Sodium Chloride Injection Bags Due to Metal Particulates

Baxter Healthcare is recalling 202,824 bags of 0.9% Sodium Chloride Injection due to the presence of metal particulate matter.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

Baxter Healthcare Corporation is recalling 202,824 bags of 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags. The recall was initiated because of the presence of particulate matter, specifically metal, in the product.

The affected product is identified by NDC 0338-0049-02 and includes specific lot numbers: C965038, C965293, C963785, C963884, C963660, C964320, C964486, and C964890. These products have an expiration date of July 31, 2016. The recalled items were distributed in the United States, Puerto Rico, and Bermuda.

Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Fluids
Hazard: particulate-matter
metal-contamination
Affected units: 202,824

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 (8)

Lot #: C965038
C965293
C963785
C963884
C963660
C964320
C964486 and C964890
Exp 7/31/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same brand · SODIUM CHLORIDE

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Same hazard · particulate matter