RecallDepth

FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065.

Company
Ethicon Endo-Surgery
Recall Initiated
November 25, 2003
Posted
December 17, 2003
Terminated
May 9, 2012
Recall Number
Z-0224-04
Quantity
45
Firm Location
Cincinnati, OH

Reason for Recall

A defective articulation band may result in improper staple formation with possible hematosis.

Distribution

The product was shipped to hospitals and distributors located nationwide and worldwide.

Lot / Code Info

Lot Numbers: T4VX78, T4WK0G, T4WL8T, T4XH6P, T4Y96L.

Root Cause

Nonconforming Material/Component

Action Taken

The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.

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