Prescription Lactated Ringers Injection Recalled for Particulate Matter
B Braun Medical Inc. is recalling 46,032 containers of Lactated Ringers Injection USP due to presence of particulate matter. The affected lot J4S807 was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I drug recall. Per the severity rubric, FDA Class I recalls are never scored below 4. Although no illnesses or injuries have been reported in the source text, the hazard of particulate matter in a direct intravenous injection carries significant risk of serious harm, justifying the Severe (4) classification.
Plain-English summary
B Braun Medical Inc. is recalling 46,032 containers of Lactated Ringers Injection USP (1000 mL) due to the presence of particulate matter. This is a Class I recall, the FDA's most serious classification level.
The recalled product contains sodium chloride, sodium lactate, potassium chloride, and calcium chloride for intravenous infusion. Lot J4S807, with an expiration date of May 31, 2027, was distributed throughout the United States.
Particulate matter in intravenous injections poses a serious risk when administered. Healthcare facilities that have this product should immediately cease using it and quarantine remaining inventory. Any adverse events associated with this product should be reported to the FDA.
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 — Injectable Solution
- Hazard
- particulate-matter
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 #: J4S807
- Exp 5/31/2027
Distribution
Distributed nationwide across the United States.
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