Recall Z-1583-2018— DeRoyal Industries Inc

Name: FDA recall Z-1583-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-23

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2018-04-23, terminated 2018-11-09. It names one FDA 510(k) clearance: K940909. 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: Non-sterile product was packaged inside a case that was labeled as sterile..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2018-04-23
Terminated: 2018-11-09
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K940909 — ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADEDebusk Technology Corp.·cleared 1994-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.