0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvi...

FDA Recall #D-0638-2024 — Class I — July 24, 2024

Recall #D-0638-2024 Date: July 24, 2024 Classification: Class I Status: Ongoing

Product Description

0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

Reason for Recall

Presence of Particulate Matter

Recalling Firm

B. Braun Medical Inc — Irvine, CA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

63,444 containers

Distribution

Nationwide within U.S.A

Code Information

Lot #: J2L763, J2L764, Exp: 31 March 2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated