FDA recall Z-1583-2018

DeRoyal Industries Inc · Class II · device

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

Reason for recall

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

Distribution

Honduras, Belgium, and The Netherlands

Key facts

Status
Terminated
Initiation date
2018-04-23
Report date
2018-05-09
Termination date
2018-11-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1583-2018