The Recall Desk
CriticalFDA (Drugs)·D-1108-2015·Announced 2015-06-03

Hospira Recalls Lactated Ringer's Irrigation Bags Due to Mold Contamination

Hospira is recalling 24,744 bags of Lactated Ringer's Irrigation due to confirmed mold contamination. The product was distributed nationwide.

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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Hospira Inc. is recalling 24,744 bags of Lactated Ringer's Irrigation, USP, 3000 mL flexible container bags. The recall is due to a confirmed customer report of dark, fibrous particulates floating within the solution, which were subsequently identified as mold.

The affected product is identified by Lot # 40-008-JT and has an expiration date of 04/01/16. The product was distributed nationwide. The agency has classified this recall as Class I.

Healthcare providers and patients should stop using the affected product immediately and contact their supplier or Hospira for further instructions.

The recalled product

Product
LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
Manufacturer
Hospira Inc.
Affected units
24,744

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 # 40-008-JT
  • Exp. 04/01/16

Distribution

Distributed nationwide across the United States.