Agency classClass IOur severity:Critical FDA (Drugs)·D-1591-2014·Announced 2014-09-24

Baxter Recalls Sodium Chloride Injection Bags Due to Particulate Matter

Baxter Healthcare is recalling specific lots of 0.9% Sodium Chloride Injection USP bags 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 classified this recall as Class I, which corresponds to a reasonable probability that use of the product may cause serious adverse health consequences or death, meeting the criteria for a Critical severity score.

Plain-English summary

Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP, packaged in 50 mL and 100 mL VIAFLEX Container bags. The recall affects specific lots of the product, which is a prescription-only intravenous solution.

The recall was initiated because particulate matter, identified as fibers and/or plastics, was found in the product. The affected lots are P309187 (50 mL bags, expiration 10/14) and P298190 (100 mL bags, expiration 08/14). The product was distributed nationwide, as well as in Puerto Rico, Singapore, and Hong Kong.

Healthcare providers and consumers should stop using the affected lots and contact Baxter Healthcare Corporation for further instructions or to arrange for a return. 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 Solution
Hazard: particulate-matter
foreign-object

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 (4)

Lot #: a) P309187
Exp 10/14
b) P298190
Exp 08/14

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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