Device Recall 3M Surgical Clipper Professional 9681 의 리콜

Recall

79289

Class 2

Z-0777-2018

2018-02-02

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161824

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.

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