Recall Z-1583-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
DeRoyal Industries Inc
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
| Date | Apr 23, 2018 |
| Status | Terminated |
| Reason | Non-sterile product was packaged inside a case that was labeled as sterile. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 1800 pencils |
| Distribution | Honduras, Belgium, and The Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940909 | ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE Debusk Technology Corp., Mar 30, 1994 |