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U.S. Department of Health and Human Services

Class 2 Device Recall NOVAPLUS

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  Class 2 Device Recall NOVAPLUS see related information
Date Initiated by Firm September 30, 2004
Date Posted October 22, 2004
Recall Status1 Terminated 3 on November 14, 2005
Recall Number Z-0037-05
Recall Event ID 30137
510(K)Number K833364  
Product Classification Electrode, Electrosurgical - Product Code JOS
Product NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
Code Information Lot 2007-06 HP
Recalling Firm/
Manufacturer
3M Company / Medical Division
3M Center, Bldg 275-05-W-06
South St Paul MN 55411
For Additional Information Contact Suzanne M. Danielson
888-280-3745
Manufacturer Reason
for Recall
Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection.
FDA Determined
Cause 2
Other
Action A recall notification letter dated 09/30/2004 was sent to Hospitals and Health Care Distributors instructing consignees to immedately remove all effective product from lot 2007-06 HP.
Quantity in Commerce 384 cases containing 40 pads each for a total of 15,360 pads
Distribution The subject product lot was distributed to the following key 3M distributors: Owens & Minor, Cardinal Health, McKesson, Professional Health Supply, and the Burrows Company.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JOS and Original Applicant = 3M COMPANY
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