Certain procedure trays contain recalled sodium chloride ampules that may pose a risk of infection or organ failure.
The Food and Drug Administration (FDA) issued an early alert regarding a potentially high-risk issue with various Becton Dickinson (BD) convenience kits and procedure trays. The agency is notifying the public that these kits may contain sodium chloride ampules manufactured by Huons Co Ltd, which were previously recalled due to sterility concerns.
If the sterility of the sodium chloride injection is compromised, patients may be exposed to microorganisms, endotoxins, and foreign matter generated during manufacturing, according to the FDA. This exposure can trigger systemic inflammatory responses, infections, micro-clots, and organ failure. As of July 29, BD has not reported any serious injuries or deaths associated with this issue.
On Aug 10, BD sent a letter to customers recommending that they stop using the sodium chloride ampules contained within the affected kits. BD says the “sodium chloride ampule is the only impacted component within the kit/tray, and all remaining components can continue to be safely used.” Healthcare facilities are advised to check their stock, quarantine affected kits until over-labels are provided, and secure an alternative local sodium chloride supply.
Upon opening a kit, the FDA suggests that healthcare professionals remove and destroy the ampule at the point of use within a controlled and sterile environment. This process ensures the sterility of the other items in the kit is maintained. For patients who have already undergone procedures using these lots, no specific follow-up is required for those who are asymptomatic, says the FDA.
The affected convenience kits contain various surgical instruments, dressings, and pharmaceutical components intended for use during surgery. The FDA says it is currently reviewing information regarding the issue and will update the public as new information becomes available.
ID 20896820 © Gradts | Dreamstime.com
