D-0431-2024Class II

B. Braun Medical Inc

Recalling firm

Product type

Drug

Status

Terminated

Report date

2024-04-10

Distribution

Nationwide in the USA

Firm state

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

2026-07-22Class IArgon Medical Devices, Inc 2026-07-22Class IIOlympus Corporation of the Americas 2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC

See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. 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.