DeRoyal SURGI MATE Electrosurgical Pencil recalled over sterility concerns

Recall date

April 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

DeRoyal Industries Inc recalls DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Prod…

Recall number

Z-1583-2018

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

Honduras, Belgium, and The Netherlands

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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