Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip electrode

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip electrode see related information
Date Initiated by Firm April 20, 2006
Date Posted May 31, 2006
Recall Status1 Terminated 3 on September 26, 2012
Recall Number Z-0919-06
Recall Event ID 35228
510(K)Number K912492  
Product Classification Spatula Electrode - Product Code GCJ
Product Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip electrode, Product Code EPS02.
Code Information Lot C4DK34 and C4DK9L.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Dave Moore
513-337-3383
Manufacturer Reason
for Recall		 There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
FDA Determined
Cause 2		 Packaging process control
Action The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
Quantity in Commerce 120 cases/6 devices per case.
Distribution The recalled product was distributed throughout the United States and to foreign consignees including Argentina, Australia, Austria, Bahrain, Brazil, Canada, China, Colombia, Czech Republic, Dominican Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela.
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 = GCJ and Original Applicant = ETHICON, INC.
-
-