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 Recall Z-1583-2018 · Posted None
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Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeGEI
Date Initiated2018-04-23
Date Terminated2018-11-09
Product Quantity1800 pencils
Reason for Recall
Non-sterile product was packaged inside a case that was labeled as sterile.
Firm 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 [email protected]
Root Cause
Process control
Distribution Pattern
Honduras, Belgium, and The Netherlands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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