Class 2 Device Recall surgical clipper

• Date Initiated by Firm: January 14, 2019
• Create Date: January 30, 2019
• Recall Status: Terminated on February 11, 2021
• Recall Number: Z-0791-2019
• Recall Event ID: 81933
• Product Classification: Razor, surgical - Product Code LWK
• Product: 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.
• Code Information: all lots
• Recalling Firm/ Manufacturer: 3M Company - Health Care Business; 3m Center 2510 Conway Ave , B# 275-5-W-6; Saint Paul MN 55144-0001
• For Additional Information Contact: 3M Health Care Customer Helpline; 800-228-3957 Ext. 6
• Manufacturer Reason for Recall: 3M has recently received reports involving the 3MTM Surgical Clipper by Remington, Model 9602, overheating in mobile/field EMS situations while charging from a modified sine wave power inverter.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, 3M Health Care, disseminated their "Field Safety Action" letter dated 1/9/2019 to its customers beginning on 01/14/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Consult facility bio-med or power inverter manual/manufacturer to ensure only pure sine wave inverters are being used in mobile/field EMS situations to charge the 9602 clipper, as emphasized in the new product caution. -Complete and return the Customer Acknowledgement Form to show your understanding of and compliance with this Field Safety Action via Email to: 3Mhealthcare@montage72.com. If you have questions regarding this matter, please contact your local 3M sales rep or the 3M Health Care Customer Helpline at 1-800-228-3957, option #6, Monday through Friday, 7:30 a.m.  6:00 p.m. Central Time.
• Quantity in Commerce: 19,860 units
• Distribution: US Distribution and countries Brazil and Canada.
• Total Product Life Cycle: TPLC 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.