FDA (Devices) recall action 84168
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Device was shipped without a Unique Device Identification (UDI) label.
Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Theralase Inc. is recalling 41 TLC-2000 Therapeutic Medical Laser Systems because they were shipped without required Unique Device Identification (UDI) labels.
Theralase Inc. is recalling 306 TLC-2002 Power Packs for the TLC-2000 Therapeutic Medical Laser System because they were shipped without a Unique Device Identification (UDI) label and incorrectly labeled as CE Marked.