Date Initiated by Firm | November 25, 2003 |
Date Posted | December 17, 2003 |
Recall Status1 |
Terminated 3 on May 09, 2012 |
Recall Number | Z-0215-04 |
Recall Event ID |
27763 |
Product Classification |
Laparoscope, Gynecologic (And Accessories) - Product Code HET
|
Product | FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063. |
Code Information |
Lot Numbers: T4W23Y, T4WA33, T4WN15, T4WN5A, T4XY22, T4XZ1E. |
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 | 210 |
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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