Lactated Ringer's containers may leak at a weld site
Lactated Ringer's Injection USP in 1000 mL Excel containers is being recalled for lack of assurance of sterility because of the potential for fluid leakage at one of the weld sites. 74,088 containers affected.
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: Risk-of-harm product: an intravenous solution with no assurance of sterility because of a potential container leak, with no infection reported.
Plain-English summary
Lactated Ringer's Injection USP, L 7500, 1000 mL Excel Container, prescription only, sterile, nonpyrogenic, single dose container, from B. Braun Medical Inc. of Bethlehem, Pennsylvania, NDC 0264-7750-00, is being recalled. The action covers 74,088 containers.
The stated reason is a lack of assurance of sterility, with the potential for fluid leakage at one of the weld sites. The FDA classified the action as Class II. The source does not report any infection or injury.
Affected lots are J5C802, J5C917 and J5C918, expiring 08/31/2027. Distribution was nationwide in the US.
Facilities should identify affected stock using the NDC and lot numbers above and follow the instructions issued by B. Braun.
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
- 74,088
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 (4)
- Lot #: J5C802
- J5C917
- J5C918
- Exp. 08/31/2027
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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