B. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling 23,688 bags of Lactated Ringer's Injection USP due to the presence of particulate matter.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
B. Braun Medical Inc. is recalling 23,688 bags of Lactated Ringer's Injection USP, 1000 mL EXCEL container. The product is a prescription-only intravenous solution containing sodium chloride, sodium lactate, potassium chloride, and calcium chloride. The recall is being conducted because of the presence of particulate matter in the product.
The affected product is identified by Lot number J4H077 with an expiration date of 30NOV2026. The NDC number is 0264-7750-00. The product was distributed nationwide in the United States.
Healthcare providers and consumers should stop using the affected product and contact B. Braun Medical Inc. for further instructions or a replacement.
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
- Affected units
- 23,688
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#: J4H077
- Exp 30NOV2026.
Distribution
Distributed nationwide across the United States.
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