0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
Product details
- 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
Company announcement
B. Braun Medical Inc. is voluntarily recalling three lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container (Lot Numbers: J6B435, J6B444, J6B457; Expiration Date: April 30, 2027).
The recall is due to the presence of particulate matter identified as zinc oxide.
The product was distributed Nationwide to hospital and healthcare facilities from February 27, 2026 to August 3, 2026.
No serious injuries, deaths, or other adverse events have been reported in connection with this issue.
Risk:
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 bloodcells). To date there have been no reports of serious injury, death or other adverse events associated with this issue.
Impacted states: Nationwide
Products:
- 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container (UPC code(s): 0264180032)
Contact
For more information, email recalls@bbraunusa.com.
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