The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- 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
Device Use
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.
