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.
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 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.
Related recalls
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16
Same hazard · mold contamination
See all →- CriticalAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-30
- SevereAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-23
- HighTurmeric capsules recalled over mold contamination in raw material lots
FDA (Food) · 2026-02-04
- HighPariva Marinated Labneh Bites Recalled Due to Potential Mold Contamination
FDA (Food) · 2024-08-21
- ModeratePariva Marinated Labneh Bites Recalled for Potential Mold Contamination
FDA (Food) · 2024-08-21
Similar recalls
- CriticalHospira Recalls Lactated Ringer's Injection Due to Mold Contamination
FDA (Drugs) · 2013-04-24
- CriticalHospira Recalls Lactated Ringer's Injection Due to Confirmed Mold Particulates
FDA (Drugs) · 2015-02-25
- CriticalHospira Recalls Lactated Ringer's Injection Due to Non-Sterility
FDA (Drugs) · 2013-04-24
- SevereHospira Recalls Lactated Ringer's Injection Due to Sterility Concerns
FDA (Drugs) · 2014-12-03
- SevereHospira Recalls Lactated Ringer's and 5% Dextrose Injection Bags
FDA (Drugs) · 2014-12-03
- LowHospira Recalls Lactated Ringer's Injection Due to CGMP Deviations
FDA (Drugs) · 2013-04-03