Class 2 Device Recall NOVAPLUS

• Date Initiated by Firm: September 30, 2004
• Date Posted: October 22, 2004
• Recall Status: Terminated 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: 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