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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 07, 2005
Date Posted February 25, 2005
Recall Status1 Terminated 3 on April 20, 2005
Recall Number Z-0563-05
Recall Event ID 31132
510(K)Number K014260  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Tissuelink Dissecting Sealer DS3.5-C, Sterile
Ref 13-121-1
Code Information Lot Number: TL033300
Recalling Firm/
TissueLink Medical, Inc.
One Washington Center
Suite 400
Dover NH 03820
For Additional Information Contact Vicki Anastasi
603-742-1515 Ext. 210
Manufacturer Reason
for Recall
The tip may separate from the device and render it unusable
FDA Determined
Cause 2
Action TissueLink notified consignees by Federal Express Letter from 2/7/05 to 2/8/05. Users are requested to return devices in inventory.
Quantity in Commerce 588 units
Distribution AZ, CA, CO, CT, DE, IL, FL, KS, KY, OH, MA, MD MO,NC, NY, PA, RI, SC, TN,TX, VA Foreign: Italy, Turkey, Egypt, Spain, Peru, Portugal, Australia, Netherlands Government: VA Medical Center 508 Fulton Street Durham, NC 27005 VA Medical Center- 7400 Merton Minter Blvd San Antonio, TX 78229 VA Medical Center- Pittsburgh University C Pittsburgh, PA 15240
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 = GEI and Original Applicant = TISSUELINK MEDICAL, INC.