March 2024 FDA Recall Lactated Ringers by B. Braun Medical Inc
D-0431-2024 - Lack of assurance of sterility
This Class II drug recall was voluntarily initiated by B. Braun Medical Inc on March 22, 2024 for the product Lactated Ringers. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0431-2024
Lack of assurance of sterility: bags have the potential to leak..
03-22-2024
04-10-2024
7,800 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
B. Braun Medical Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
07-01-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Batch or Lot Expiration Information
Lot# : J3N023, Exp: 31 March 2026
