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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Red Dot Monitoring Electrode, Catalog 2560 &38 & Novaplus Universal Monitoring Electrode V2560

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 Class 2 Recall
3M Red Dot Monitoring Electrode, Catalog 2560 &38 & Novaplus Universal Monitoring Electrode V2560
see related information
Date Posted September 07, 2010
Recall Status1 Terminated on April 19, 2012
Recall Number Z-2383-2010
Recall Event ID 56488
Premarket Notification
510(K) Number
K970796 
Product Classification Electrode, Electrocardiograph - Product Code DRX
Product 3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.
Code Information 2560 LOT #'S: 2012-06 CX, 2012-06 CY, 2012-06 CZ, 2012-06 DA, 2012-06 DB, 2012-05 CN, 2012-05 CM, 2012-05 CK, 2012-05 CJ, 2012-05 CI, 2012-05 CH,2012-05 CG, 2012-05 CF, 2012-05 CE, 2012-05 CD, and 2012-05 CC. V2560 NOVATION PRIVATE LABEL LOT: 2012-05 CL.
Recalling Firm/
Manufacturer
3M Company / Medical Division
3M Center, Bldg 275-05-W-06
Saint Paul, Minnesota 55144
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action 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.
Quantity in Commerce 11,063 cases (20 pouches/case, 50 electrodes/pouch)
Distribution Nationwide Distribution: States of CA, FL, IL, KS, KY, MI, MO, NE, NJ, NY, OH, PA, RI, SD, TN, VA, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DRX and Original Applicant = 3M HEALTH CARE
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