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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch

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 Class 2 Device Recall DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switchsee related information
Date Initiated by FirmApril 23, 2018
Create DateMay 01, 2018
Recall Status1 Terminated 3 on November 09, 2018
Recall NumberZ-1583-2018
Recall Event ID 79939
510(K)NumberK940909 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductDeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
Code Information Lot Number 44210051
FEI Number 1043214
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact
865-938-7828
Manufacturer Reason
for Recall		Non-sterile product was packaged inside a case that was labeled as sterile.
FDA Determined
Cause 2		Process control
ActionDeRoyal 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 in Commerce1800 pencils
DistributionHonduras, Belgium, and The Netherlands
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
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