B. Braun recalls IV solutions over serious patient safety risks
B. Braun Medical has issued a recall on two of its intravenous fluid products due to the presence of particulate matter in the bags. While no serious injuries or deaths have been reported, if bits of plastic material enter the bloodstream, they can cause blockages in blood vessels and organ damage that could be fatal.
According to an announcement released by the U.S. Food and Drug Administration (FDA) on Aug. 19, the recalled lots are of USP 1,000 milliliter and 0.9% sodium chloride injection USP 1,000 milliliter IV infusion products.
Specific identifiers can be seen in the following chart:
B. Braun is asking customers to quarantine any IV solutions impacted by the recall. They cannot be safely used on patients. However, it said none of the recalled products should be destroyed; rather, they are to be returned to the company for a refund.
All known customers should have received a form to initiate a refund or exchange. If not, B. Braun can be contacted at 844-903-6417.
The FDA asks that any adverse events be reported to the agency’s MedWatch program. The form to do so is available here.
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