Lactated Ringer's injection containers recalled over presence of particulate matter
B. Braun Lactated Ringer's Injection USP in 1000 mL containers, lot J4S807, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 46,032 containers are affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this particulate matter action as Class I.
Plain-English summary
Lactated Ringer's Injection USP in 1000 mL containers, available on prescription only, from B. Braun Medical, Inc. of Bethlehem, Pennsylvania, NDC 0264-7750-07, is being recalled. The affected product is lot J4S807 with an expiry of 5/31/2027, and the recall covers 46,032 containers distributed nationwide.
The recall was issued for the presence of particulate matter. The FDA classified the action as Class I, its most serious category.
Hospitals and pharmacies holding this lot should quarantine it, stop using it, and follow B. Braun's instructions for return or 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
- Affected units
- 46,032
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.
Part of a larger recall action
This product is one of 2 recalled by B BRAUN MEDICAL INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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