ICU Medical Inc. has issued a voluntary recall for four specified lots of intravenous sodium chloride solutions and one specified lot of intravenous dextrose solution due to the potential for flexible container leaks. The recall was reported to the U.S. Food and Drug Administration (FDA), and the information on affected lots is included in the June 27 edition of the FDA’s Enforcement Report. Individual product distributors are also contacting customers known to have purchased affected lots.If you have any units from affected lots, ICU Medical advises you to:
Stop the use and distribution of the affected product immediately.
Inform potential users of the product in your organization of the notification and complete a response form available from ICU Medical.
Return any affected product using instructions provided by ICU Medical.
If you have further distributed the product, immediately convey this notification to anyone who may have received it according to instructions from ICU Medical.
For further information, contact ICU Medical at 1-844-654-7780 (global complaint management and drug safety) or 1-800-241-4002, Option 6 (medical information).