Agency classClass IOur severity:Critical FDA (Drugs)·D-1592-2014·Announced 2014-09-24

Baxter Recalls Sodium Chloride Injection Bags Due to Particulate Matter

Baxter Healthcare is recalling 390,560 bags of 0.9% Sodium Chloride Injection USP due to the presence of particulate matter, including fibers and plastics.

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 (5).

Plain-English summary

Baxter Healthcare Corporation is recalling 390,560 bags of 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags. The recall is being conducted because particulate matter, identified as fibers and/or plastics, was found in the product. The affected product is identified by Lot # P308650 and has an expiration date of 10/14.

The recalled product was distributed nationwide, as well as in Puerto Rico, Singapore, and Hong Kong. This is a prescription-only medication intended for intravenous use. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.

Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the distributor or the manufacturer for credit or replacement.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — IV Fluids
Hazard: particulate-matter
contamination
Affected units: 390,560

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)

Lot #: P308650
Exp 10/14

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 3 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 3 products in this recall →

Same brand · SODIUM CHLORIDE

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Same manufacturer · Baxter Healthcare Corp.

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Same hazard · particulate matter