Lactated Ringers IV Solution Recall: Potential Sterility Failure Risk from Bag Leakage
B. Braun Medical Inc. is recalling approximately 7,800 bags of Lactated Ringers IV solution (Lot J3N023, exp. March 31, 2026) distributed nationwide due to potential leakage that could compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a high-risk intravenous product where sterility failure could lead to serious infection. However, no illnesses or injuries have been reported, and the hazard is theoretical (potential leakage) rather than confirmed. Per the rubric, products with risk of harm but no reported injury score at most 3.
Plain-English summary
B. Braun Medical Inc. is recalling Lactated Ringers Injection USP, a sterile intravenous solution supplied in 1000mL EXCEL containers. The affected product is Lot J3N023 with an expiration date of March 31, 2026, distributed nationwide in the United States. Approximately 7,800 bags are subject to this recall.
The recall was initiated due to lack of assurance of sterility. The bags have the potential to leak, which could compromise the sterile integrity required for intravenous administration.
Lactated Ringers is an electrolyte solution used in medical settings for intravenous fluid replacement. The potential for bag leakage could allow contamination of the product.
The recalled product
- Product
- LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
- Brand
- LACTATED RINGERS
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Intravenous Solution
- Hazard
- sterility-failure
- leakage
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 #: J3N023
- Exp: 31 March 2026
Distribution
Distributed nationwide across the United States.
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