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U.S. Department of Health and Human Services

Class 2 Device Recall Endopath 5mm Curved Dissector

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  Class 2 Device Recall Endopath 5mm Curved Dissector see related information
Date Initiated by Firm November 06, 2007
Date Posted January 29, 2008
Recall Status1 Terminated 3 on December 09, 2009
Recall Number Z-0565-2008
Recall Event ID 45869
510(K)Number K984240  
Product Classification Surgical Dissector - Product Code GDI
Product Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242
Code Information Lot No: D4HZ9Y.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Dave Moore
513-337-7000
Manufacturer Reason
for Recall		 Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.
FDA Determined
Cause 2		 Process control
Action Endopath sent consignees an Urgent Device Recall notification letter on or about 11/15/07, informing them that the possibility exists that damage to the packaging of this product may have compromised the sterility of the product. The firms were told to examine their inventory, and remove all affected product. All consignees were instructed to complete the Business Reply Form; even if they did not have any product. Recalled products are to be returned to Ethicon for a credit.
Quantity in Commerce 2,844
Distribution Worldwide, USA including states of AL, AR, AZ, CA, CO, DE, FL, GA, IL, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NV, NY, OH, PA, RI, TN, TX, AND WA, and countries of Austria, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Greece, Hong Kong, Italy, Japan, Korea, Mexico, Portugal, Puerto Rico, Republic of Panama, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, and 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 = GDI and Original Applicant = ETHICON ENDO-SURGERY, INC.
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