3M Surgical Clipper Professional 9681
3M Company - Health Care Business began a recall of 3M Surgical Clipper Professional 9681 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0777-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- 3M Company
- Product
- 3M Surgical Clipper Professional 9681
- Product code
- LWK Razor, Surgical
- 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.
- Root cause tag
- labeling and UDI
- FDA 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 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.
- Product codes and lots
- all
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0777-2018 | Class II | Terminated | Voluntary: Firm initiated |
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