Device Recall 3M Red Dot Monitoring Electrode, Catalog 2560 &38 & Novaplus Universal Monitoring Electrode V2560 의 리콜

Recall

56488

Class 2

Z-2383-2010

2010-07-27

2010-09-07

Terminated

United States

2012-04-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93771

The sensing element of the 3m red dot monitoring electrode, catalog # 2560 and novaplus universal monitoring electrode #v2560 may have corrosion. in an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response.

3M sent an "Urgent Medical Device Recall" letters and a "Distributor Product Recall Form" dated July 29, 2010 to customers and distributors of the 3M and Novaplus electrodes. The letters described the 3M Red Dot and Novaplus Universal products, problems and actions to be taken by customers. Customers were instructed to examine their inventory and quarantine the affected lots pending return to the firm. After completing and returning the enclosed Customer Product Recall Form to 3M, customers will be issued a Return Authorization Number and provided with instructions for return of the affected devices. Distributors were instructed to notify customers to the end user level and have them return affected lots to the distributor for forwarding to 3M, or forward the customer letter to end-users to instruct them on how to contact 3M for recovery of the device. The 3M Customer Helpline can be contacted at: 1-800-228-3957.