Date Initiated by Firm |
November 25, 2003 |
Date Posted |
December 17, 2003 |
Recall Status1 |
Terminated 3 on May 09, 2012 |
Recall Number |
Z-0224-04 |
Recall Event ID |
27763 |
Product Classification |
Laparoscope, Gynecologic (And Accessories) - Product Code HET
|
Product |
FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065. |
Code Information |
Lot Numbers: T4VX78, T4WK0G, T4WL8T, T4XH6P, T4Y96L. |
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 |
45 |
Distribution |
The product was shipped to hospitals and distributors located nationwide and worldwide. |
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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