Recall Z-0777-2018 ยท LWK Razor, Surgical
3M Company - Health Care Business
3M Surgical Clipper Professional 9681
| Date | Feb 2, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 res |
| Quantity | 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 Thai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.