Class I recall: B BRAUN MEDICAL INC: 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container
The FDA has issued a Class I recall for B. Braun Medical's 0.9% Sodium Chloride Injection, USP, 100 mL partial fill in 150 mL PAB containers (NDC 0264-1800-32), citing the presence of particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber, or polystyrene. The recall is classified as Class I, the FDA's most serious designation, indicating use of the affected product could cause serious injury or death.
Most relevant for: Clinicians administering IV saline infusions to patients in gynecologic or obstetric care settings using this specific lot of B. Braun saline product.
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