LTS Therapy Systems, LLC: IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

Hazard

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

Details from the source

Reason for recall: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. Distribution: US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota. Quantity: 80928 units Lot/code info: Lot Code: UDI-DI: (01) 10815611020005 UDI-PI: (10) 4283 Lot numbers: 4283-1, 4283-2, 4283-3, 4283-4

UPC codes

10815611020005

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.