| Class 2 Device Recall Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 29cm length, hollow tip electrode. | |
Date Initiated by Firm | April 20, 2006 |
Date Posted | May 31, 2006 |
Recall Status1 |
Terminated 3 on September 26, 2012 |
Recall Number | Z-0922-06 |
Recall Event ID |
35228 |
510(K)Number | K912492 |
Product Classification |
Probe, Spatula Electrode - Product Code GCJ
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Product | Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 29cm length, hollow tip electrode, Code EPS06. |
Code Information |
Lot C4DK35, C4DL86, and C4DN7U. |
Recalling Firm/ Manufacturer |
Ethicon Endo-Surgery Inc 4545 Creek Rd Cincinnati OH 45242-2803
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GCJ
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