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U.S. Department of Health and Human Services

Class 2 Device Recall surgical clipper

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  Class 2 Device Recall surgical clipper see related information
Date Initiated by Firm January 14, 2019
Create Date January 30, 2019
Recall Status1 Terminated 3 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 2		 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.
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