FDA Recall Alert: B. Braun Lactated Ringer’s Injection USP 1 L Contaminated with Particulates
Immediate action required for healthcare providers: On 08 May 2024, B. Braun Medical Inc. announced a voluntary nationwide recall of two lots of Lactated Ringer’s Injection, USP, 1 L (catalog E7500) after visible particulate matter was identified. Infusion of contaminated solution can result in pulmonary embolism, vessel occlusion, or other life-threatening events. Verify inventory against the recalled lot numbers listed below and quarantine affected bags without delay.
Reasons for the B. Braun Lactated Ringer’s Recall
Company testing and customer reports detected cellulose and stearate particles, plus trace inorganic material (including copper) suspended in the IV fluid. Potential clinical consequences include:
- Obstruction of pulmonary or peripheral vasculature leading to tissue ischemia
- Phlebitis, hemolysis, or systemic inflammatory response
- Permanent impairment or death in severe cases
Product Identification and Lot Numbers
- Product: Lactated Ringer’s Injection, USP, 1 L (plastic container)
- Catalog number: E7500
- NDC: 0264-7750-07
- Package: Case of 12 sterile, non-pyrogenic containers
Recalled Lots
| Lot # | Distribution Window | Expiration | Market |
|---|---|---|---|
| J4P756 | 15 Nov 2024 – 06 Mar 2025 | 31 May 2027 | United States (nationwide) |
| J4S843 | 13 Jan 2025 – 15 May 2025 | 31 May 2027 | United States (nationwide) |
Sources
Required Actions for Hospitals and Distributors
- Locate and quarantine all inventory bearing lot numbers J4P756 or J4S843.
- Discontinue use immediately.
- Complete the enclosed Urgent Pharmaceutical Recall Acknowledgement form.
- Contact the B. Braun Recalls Department to arrange product return and credit.
How to Contact the B. Braun Recalls Department
- Recall hotline: 844-903-6417 (Mon–Fri, 8 a.m.–5 p.m. ET)
- Email: recalls@bbraunusa.com
Adverse reactions or quality problems experienced with use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Official Recall Images
Frequently Asked Questions About the B. Braun Lactated Ringer’s Recall
1. Why is B. Braun recalling Lactated Ringer’s Injection?
Testing confirmed cellulose, stearate, and trace metal particles in the solution, which can cause embolic or inflammatory complications if infused.
2. Which lot numbers of B. Braun Lactated Ringer’s Injection are affected?
Only lots J4P756 and J4S843 are subject to this recall.
3. Is B. Braun Lactated Ringer’s Injection safe to use if no particles are visible?
No. The company directs all facilities to stop use and return bags from the recalled lots even when particulate matter is not visibly present.
4. Can in-line filtration make the recalled B. Braun Lactated Ringer’s Injection usable?
Filtration is not an acceptable mitigation; the recall mandates complete removal and return of the affected product.
5. How do I obtain credit for returned B. Braun Lactated Ringer’s Injection?
Fill out the Urgent Pharmaceutical Recall Acknowledgement form and coordinate with the Recalls Department via 844-903-6417 or recalls@bbraunusa.com.
6. What patient symptoms should trigger reporting after B. Braun Lactated Ringer’s Injection infusion?
Watch for respiratory distress, chest pain, unexplained hypoxia, phlebitis, hemolysis, or organ dysfunction and report through FDA MedWatch.
7. Will alternative B. Braun Lactated Ringer’s Injection lots remain available?
Yes. Only the two specified lots are recalled; other lots meeting quality specifications remain on the market.