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Terminated

FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56.

FDA Recall Z-0223-04 · Posted 2003-12-17

Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeLFL
Date Initiated2003-11-25
Date Terminated2012-05-09
Product Quantity6

Reason for Recall

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

Firm Action

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

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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