The Recall Desk
ModerateFDA (Drugs)·D-1282-2014·Announced 2014-05-07

Baxter Recalls 0.9% Sodium Chloride Irrigation Due to Nylon Fibers

Baxter Healthcare Corp. is recalling 211,752 bottles of 0.9% Sodium Chloride Irrigation, USP, 1000 mL, due to the presence of nylon fibers.

What this means for you

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 hazard involves particulate matter (nylon fibers) in an irrigation solution, which fits the criteria for moderate risk without reported serious injuries.

Plain-English summary

Baxter Healthcare Corp. is recalling 211,752 bottles of 0.9% Sodium Chloride Irrigation, USP, 1000 mL, Not for Injection. The product is identified by NDC 0338-0048-04, Lot # Gl09272, and an expiration date of 09/16.

The recall was initiated because nylon fibers were found in a bottle of the irrigation solution. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact Baxter Healthcare Corp. for further instructions or a refund.

The recalled product

Product
SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand
SODIUM CHLORIDE
Affected units
211,752

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 # Gl09272
  • Exp 09/16

Distribution

Distributed nationwide across the United States.