D-0431-2024 Class II Terminated

Recalled by B. Braun Medical Inc — Irvine, CA

FDA drug recall D-0431-2024 was initiated by B. Braun Medical Inc on Mar 22, 2024 and is designated Class II. Reason for recall: Lack of assurance of sterility: bags have the potential to leak.. The recall status is terminated (terminated Jul 1, 2025). Affected quantity: 7,800 bags.

Recall Details

Product Type
Drugs
Report Date
Apr 10, 2024
Initiation Date
Mar 22, 2024
Termination Date
Jul 1, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,800 bags

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: J3N023, Exp: 31 March 2026

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0431-2024
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.