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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Endopath Probe Plus II, Right Ange Electrode, 5 mm 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-0920-06
Recall Event ID 35228
510(K)Number K912492  
Product Classification Probe, Right Ange Electrode - Product Code GCJ
Product Endopath Probe Plus II, Right Ange Electrode, 5 mm shaft, 34 cm length, hollow tip electrode, Product Code EPS03.
Code Information Lot C4DD4K, C4DJ5E, C4DK9M, and C4DN5E.
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 288cases/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.
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