Class 2 Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter

Date Initiated by Firm	November 25, 2003
Date Posted	December 17, 2003
Recall Status¹	Terminated ³ on May 09, 2012
Recall Number	Z-0221-04
Recall Event ID	27763
Product Classification	Instrument, Ultrasonic Surgical - Product Code LFL
Product	General Laparoscopic Tray, Product #TGL33.
Code Information	Lot Numbers: T4WF6D, T4WT8Y, T4X52J, T4Y03E.
Recalling Firm/ Manufacturer	Ethicon Endo-Surgery 4545 Creek Rd Cincinnati OH 45242-2803
For Additional Information Contact	Mr. Dirk Stevens 513-337-7501
Manufacturer Reason for Recall	A defective articulation band may result in improper staple formation with possible hematosis.
FDA Determined Cause ²	Nonconforming Material/Component
Action	The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
Quantity in Commerce	36
Distribution	The product was shipped to hospitals and distributors located nationwide and worldwide.
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.