Lactated Ringers Injection Recalled for Particulate Matter Contamination
B. Braun Medical Inc. is recalling Lactated Ringer's Injection USP (1000 mL containers) due to the presence of particulate matter. The recall affects 95,412 containers 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 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 FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls with no reported illnesses must still be scored at minimum 4 (Severe). Particulate matter in an intravenous solution poses a direct risk of harm to patients.
Plain-English summary
B. Braun Medical Inc. is recalling Lactated Ringer's Injection USP, 1000 mL containers (NDC 0264-7750-07), due to the presence of particulate matter. The affected lots are J4P756 and J4S843, with an expiration date of 5/31/2027. Approximately 95,412 containers have been distributed throughout the United States.
Lactated Ringer's Injection is an intravenous solution containing sodium chloride, sodium lactate, potassium chloride, and calcium chloride. It is distributed by B. Braun Medical Inc., located in Bethlehem, Pennsylvania.
Patients and healthcare providers who have received or are using this product should discontinue use and contact B. Braun Medical Inc. or their healthcare provider for further guidance. Healthcare facilities should check their inventory for the affected lot numbers and quarantine any units identified.
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
- Affected units
- 95,412
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 (3)
- Lot #:J4P756
- J4S843
- Exp 5/31/2027
Distribution
Distributed nationwide across the United States.
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