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
|