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Class 2 Device Recall |
![see related information](../images/related-info.gif) |
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
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Product Classification |
Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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Product |
Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1 |
Code Information |
Lot Number: TL033300 |
Recalling Firm/ Manufacturer |
TissueLink Medical, Inc. One Washington Center Suite 400 Dover NH 03820
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For Additional Information Contact |
Vicki Anastasi 603-742-1515 Ext. 210
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Manufacturer Reason for Recall |
The tip may separate from the device and render it unusable
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FDA Determined Cause 2 |
Other |
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
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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 = GEI and Original Applicant = TISSUELINK MEDICAL, INC.
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