FDA Device

DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical

Hazard

Non-sterile product was packaged inside a case that was labeled as sterile.

What You Should Do

Remedy

DeRoyal sent an Urgent Recall Notice letter dated April 23, 2018 to affected customers. The letter identified the affected products, problems and actions to be taken. The recall notices requested destruction of the product at the consignee level. Distributors were asked to notify their consignees or to provide the list to DeRoyal for notification. For questions contact your DeRoyal Representative, customer service at 888-938-7828 or by email at recalls@deroyal.com

Products

DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
Brand
DeRoyal Industries Inc
UPC
Lot Number 44210051

Units Affected

1800 pencils