Class 2 Device Recall TissueLink

• Date Initiated by Firm: July 22, 2004
• Date Posted: September 01, 2004
• Recall Status: Terminated on October 04, 2004
• Recall Number: Z-1416-04
• Recall Event ID: 29697
• 510(K)Number: K020574 K022532
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device
• Code Information: Lot Numbers: TLK17300, TLB02400
• Recalling Firm/ Manufacturer: TissueLink Medical, Inc.; One Washington Center; Suite 400; Dover NH 03820
• For Additional Information Contact: Vicki S. Anastasi; 603-742-1515 Ext. 210
• Manufacturer Reason for Recall: Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.
• FDA Determined Cause: Other
• Action: TissueLink notified the sales force on 7/22/04 to visit each account and retreive product at the hospital level.
• Quantity in Commerce: 96 units
• Distribution: Nationwide
• 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