On September 20, 2023, the U.S. Food and Drug Administration (FDA) announced that Medline Industries had recalled a single lot of Hudson RCI AddiPak® unit dose vial, 0.9% full normal saline solution, because it may be nonsterile. FDA identified it as a class I recall, the most serious type of recall, where usage may cause serious injuries or death.
The recall affects 18,000 units with lot number 3B085, which were distributed in the United States from April 20–July 14, 2023. Medline Industries said that the affected lot passed sterility testing; however, another lot (number 3B087) cleaned during the same cycle failed sterility testing, exposing the affected lot to potential contamination.
Use of nonsterile saline may cause serious adverse health consequences, including difficulty breathing, general discomfort, nausea, wheezing, and infection, Medline Industries said. Infection can lead to life-threatening sepsis and death. Medline Industries said that it has received no reports of injuries or death associated with the recall.
On August 4, 2023, Medline Industries requested all affected customers to:
- Check stock immediately for the affected item number and the affected lot numbers listed on the recall portal.
- Complete the response form (recall reference # R-23-122), listing the quantity of affected product in inventory, even if they do not have any affected product in inventory.
- Destroy the affected product after completing the form. (All accounts will be credited with a refund once the response form is submitted.)
Medline Industries also requested all distributors to:
- As required by law, notify FDA of Medline Industries’ recall communication if they resold or transferred the product to another company or individual.
- Include their customers’ quantities on their response form (recall reference #: R-23-122) and instruct their customers to document and destroy any affected product.
U.S. customers with questions about the recall should contact Medline Industries’ Recall Department at 866-359-1704. Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.