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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Surgical Clipper Professional 9681

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  Class 2 Device Recall 3M Surgical Clipper Professional 9681 see related information
Date Initiated by Firm February 02, 2018
Create Date February 28, 2018
Recall Status1 Open3, Classified
Recall Number Z-0777-2018
Recall Event ID 79289
Product Classification Razor, surgical - Product Code LWK
Product 3M Surgical Clipper Professional 9681
Code Information all
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
800-228-9357
Manufacturer Reason
for Recall
Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy.
FDA Determined
Cause 2
Labeling design
Action The firm initiated their field safety action on 02/08/2018 by certified mail to customers and distributors. Larger distributor were notified by email on 02/12/2018. The notices to the distributors stated: "3M is notifying all users of the 3M" Surgical Clipper Professional 9681 of an added product warning, stressing the importance of following proper clipper charging practices as documented in the Model 9681 Clipper instructions for use. Current charging instructions recommend leaving the clipper body in the drop-in charger in between uses. Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy. 3M has received two reports of battery venting resulting in minor burn injury. 3M is adding the following product warning to emphasize the importance of proper charging practices: Warning: To avoid potential battery degradation, charge the clipper after each use and store in the drop-in charger stand when not in use. Distributors are being asked to take the following actions: " Identify those customers who have ordered the 3M" Surgical Clipper Professional 9681 or the 3M" Surgical Professional Clipper Blades 9680 beginning January 1, 2016 to date. " Communicate this Field Safety Notice to those customers." The notice to the customer stated the following: "3M is notifying all users of the 3M" Surgical Clipper Professional 9681 of an added product warning, stressing the importance of following proper clipper charging practices as documented in the Model 9681 Clipper instructions for use. Current charging instructions recommend leaving the clipper body in the drop-in charger in between uses. Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat durin
Quantity in Commerce 120000 units
Distribution Worldwide distribution including US nationwide, including Puerto Rico. Singapore, Australia, Canada, Chile, Colombia, Costa Rica, Brazil, Dominica, Ecuador, Guatemala, UAE, Israel, Japan, Korea, Mexico, new Zealand, Paraguay, Peru, Taiwan, Uruguay, India, Bolivia, El Salvador, Saudi Arabia, and Thailand.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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