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The U.S. Food and Drug Administration (FDA) is aware that Becton Dickinson & Company has issued a letter to affected customers recommending all anesthesia trays be corrected prior to continued use by removing the Bupivacaine ampules.
Becton Dickinson & Company stated Huons Co., Ltd. manufactured bupivacaine ampules were recalled due to quality issues identified during a recent FDA inspection and limited reports of drug ineffectiveness. These ampules are included in BD Spinal Trays. Risks of using compromised injectables include localized infection, inflammatory response or reduced anesthetic effectiveness.
As of April 27, Becton Dickinson has reported no serious injuries or deaths associated with this issue.
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Becton Dickinson & Company at BDRC9@bd.com or 1-844-823-5433.
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