# Ne oldu?

B. Braun Medical Inc. announced a voluntary nationwide recall of three specific lots of 0.9% Sodium Chloride Injection USP, 100 mL, packaged in 150 mL PAB® containers. The recall was initiated after zinc oxide particulate matter was identified in the affected product during routine quality checks. The company is working with distributors and healthcare facilities to retrieve the impacted units.

# Ayrıntılar

The recall encompasses three lots of the 0.9% Sodium Chloride Injection USP, 100 mL strength, presented in a 150 mL PAB® container. Particulate matter, specifically identified as zinc oxide, was discovered in the affected batches. Administration of intravenous solutions containing foreign particles carries significant risk. The FDA and B. Braun have classified this as a Class I recall, the most serious type, indicating that use of the product may cause serious adverse health consequences or death.

Risk Statement: Administration of 0.9% Sodium Chloride Injection USP, found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells).

# Neden önemli?

This recall is significant because 0.9% Sodium Chloride Injection is a commonly used intravenous fluid found in hospitals and clinical settings across the United States. The presence of particulate matter in an injectable solution is a critical quality failure that can lead to immediate and severe patient harm. Given the widespread use of saline injections for hydration, medication dilution, and IV therapy, the potential exposure of patients to contaminated product is a major patient safety concern. The recall underscores the importance of rigorous manufacturing quality controls to prevent foreign material contamination.

# Arka plan

Intravenous saline solutions are among the most frequently administered medications in healthcare. The PAB® (Plastic Ampoule Bottle) container system is designed as a non-PVC, non-DEHP flexible packaging option. The discovery of zinc oxide particulate matter represents a deviation from sterility and purity standards. While no adverse events have been reported to date in connection with this specific recall, the potential for harm is inherent in the infusion of foreign particles into the bloodstream. B. Braun has stated that the recall is being conducted out of an abundance of caution and commitment to patient safety.

# Sırada ne var?

Healthcare providers are advised to check their inventory for the affected lots and immediately quarantine any units matching the recalled identifiers. Distribution of the recalled lots has been halted, and B. Braun is facilitating the return process. Patients currently receiving intravenous therapy should consult their healthcare team if they have concerns about the specific fluid being administered. Further updates will be provided as the recall process progresses and additional lot information becomes available.