The Recall Desk
CriticalFDA (Drugs)·D-1550-2014·Announced 2014-08-27

Baxter Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter

Baxter Healthcare is recalling 4,200 containers of 0.9% Sodium Chloride Injection because blue polyisoprene shavings were found inside the bag port tubes.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 the 'Critical' severity score in the rubric.

Plain-English summary

Baxter Healthcare Corporation is recalling 4,200 containers of 0.9% Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container. The affected product is identified by Lot C931923 with an expiration date of 8/31/2015. The recall was initiated due to the presence of particulate matter, specifically blue polyisoprene shavings found inside the bag port tubes.

The affected product was distributed nationwide. The FDA has classified this recall as Class I, which is the most serious classification for drug recalls.

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

The recalled product

Product
0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
Affected units
4,200

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 C931923
  • exp 8/31/2015

Distribution

Distributed nationwide across the United States.