B. Braun Lactated Ringers 1000 mL Recall (Lot J4H077): FDA Safety Alert
Urgent for hospitals and clinics: B. Braun Medical Inc. has voluntarily recalled one lot of Excel® Lactated Ringers Injection, 1000 mL, after visible particulate—mostly cellulose cotton fibers—was detected. Infusing contaminated solution can lead to pulmonary emboli, vessel occlusion, phlebitis, systemic immune responses, hemolysis, and other life-threatening events. Do not use or distribute lot J4H077—quarantine and return it immediately.
B. Braun Lactated Ringers Recall Details (Lot J4H077)
- Manufacturer: B. Braun Medical Inc.
- Product: Excel® Lactated Ringers Injection, 1000 mL (non-PVC, non-DEHP flexible container)
- Catalog #: L7500
- NDC: 0264-7750-00
- Affected lot: J4H077 | Expires: 30 NOV 2026
- Distribution dates: 29 Aug – 30 Sep 2024 (U.S. & Canada)
- Recall announced: 19 Aug 2026
- Hazards: Pulmonary emboli, vessel occlusion, phlebitis, systemic immune activation, hemolysis
- Injuries reported: None as of the announcement date
Sources
Immediate Actions for Hospitals & Clinics
- Identify and quarantine every unit labeled lot J4H077.
- Do not infuse the solution into any patient.
- Return affected stock through normal channels for credit or replacement.
- Alert pharmacy, nursing, anesthesia, and materials management teams.
- Report adverse events to FDA MedWatch:
- Online: fda.gov/MedWatch/report.htm
- Mail/Fax: Forms at fda.gov/MedWatch/getforms.htm or call 1-800-332-1088
B. Braun Recall Contact
Email: recalls@bbraunusa.com
Hours: Monday–Friday, 8 a.m.–5 p.m. EST
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B. Braun Lactated Ringers Recall FAQ
- 1. Why is B. Braun Excel Lactated Ringers Injection being recalled?
- Particulate matter—primarily cellulose fibers and polystyrene—was discovered in lot J4H077, posing a risk of emboli and other serious IV complications.
- 2. How do I confirm that my Lactated Ringers 1000 mL bag is from the recalled lot?
- Match these identifiers: Catalog L7500, NDC 0264-7750-00, lot J4H077, expiration 30 NOV 2026.
- 3. What immediate steps should I take with recalled B. Braun Lactated Ringers bags?
- Stop use, quarantine the product, notify relevant departments, and arrange return or replacement per the recall instructions.
- 4. Have any patient injuries been linked to the B. Braun Lactated Ringers recall?
- No injuries or adverse events had been reported to the FDA or B. Braun as of 19 Aug 2026.
- 5. Who should I contact at B. Braun for recall logistics?
- Email recalls@bbraunusa.com during business hours for return authorization or questions.
- 6. Can the particulate in B. Braun Lactated Ringers be filtered out at the bedside?
- No. Standard in-line IV filters are not validated to remove cellulose fibers reliably. Use of the recalled product is contraindicated.
- 7. Does this B. Braun recall affect other Lactated Ringers sizes or lots?
- Only lot J4H077 of the 1000 mL Excel® bag is subject to the recall. All other lots and sizes remain on the market.