Medline Industries has issued a recall for their Hudson RCI Addipak Unit Dose Vial, specifically the 0.9% Full Normal Saline Solution, due to a critical issue of non-sterility. This announcement comes as a grave cause for alarm, as the U.S. Food and Drug Administration (FDA) has categorized it as a Class I recall, which is the most severe and urgent type of product recall.
• Product Names: Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution
• Product Codes: See Recall Database Entry
• Lot number: 3B085
• Distribution Dates: April 20, 2023 to July 14, 2023
• Devices Recalled in the U.S.: 18,000
• Date Initiated by Firm: July 24, 2023
The Hudson RCI Addipak Unit Dose Vials is a pack of single use 0.9% Full Normal Saline Solution used during treatments such as inhalation and irrigation therapy. It may be used with a non-ventilatory nebulizer to clean the lungs or for tracheal irrigation. For inhalation therapy, the saline solution restores moisture to the lungs, relieves congestion caused by colds or allergies, or dilutes bronchodilator (rescue inhaler) solutions that require dilution. For irrigation therapy, the saline solution is used for wound cleansing and flushing.
Reason for Recall
Medline Industries is recalling the Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution (Lot 3B085) due to being non-sterile. The affected lot passed sterility testing, however, another lot within the same cleaning cycle (Lot 3B087) failed sterility testing, exposing the affected lot to potential contamination.
The use of non-sterile saline may cause serious adverse health consequences including difficulty breathing, general discomfort, nausea, wheezing, and infection. Infection can lead to life-threatening sepsis, and death.
There have been no reports of injuries or death associated with this issue.
Who May be Affected
• People who use Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution for inhalation and irrigation therapy.
• Health care personnel who prescribe or provide inhalation or irrigation therapy.
What to Do
On August 4, 2023, Medline Industries sent all affected customers a recall letter.
The letter requested customers to:
• Check stock immediately for the affected item number and the affected lot numbers listed on the recall portal.
• Use the link and the information below to complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form.
• The login for completing the response form is:
Recall Reference #: R-23-122
• Destroy affected product upon completion of the form. Your account will receive credit once the response form is submitted.
The letter requested distributors to:
• Notify the FDA of this recall communication if you have resold or transferred this product to another company or individual. This is required by law.
• Instruct customers to document and destroy any affected product. Include your customers quantities on your response form.
Customers in the U.S. with questions about this recall should contact the Medline Industries Recall Department at 866-359-1704.
• Medical Device Recall Database Entry
How do I report a problem?
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.