LTS Therapy Systems, LLC: IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The 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: 63936 units Lot/code info: Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3

UPC codes

10815611020012

Source

Official record: FDA (Device enforcement) ↗

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