← FDA ENFORCEMENT
D-0431-2024Class II

B. Braun Medical Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
B. Braun Medical Inc
Product type
Drug
Status
Terminated
Report date
2024-04-10
Distribution
Nationwide in the USA
Firm state
CA
Product quantity
7,800 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of assurance of sterility: bags have the potential to leak..

Product description

Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00

Code / lot info

Lot #: J3N023, Exp: 31 March 2026

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →