—#163991

Product

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

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K940909
Affected lot / code info: Lot Number 44210051

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Honduras, Belgium, and The Netherlands

Timeline

Recall initiated: 2018-04-23
Terminated: 2018-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163991. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.