Z-0224-04

FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065

Name: Z-0224-04 FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065
Creator: Ethicon Endo-Surgery
Published: 2003-11-25
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2003-11-25 / Terminated / root cause: manufacturing process

FDA source

Ethicon Endo-Surgery began a recall of FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065 on 2003-11-25. The reason FDA records is "A defective articulation band may result in improper staple formation with possible hematosis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0224-04
Status: Terminated
Initiated: 2003-11-25
Posted: 2003-12-17
Terminated: 2012-05-09
Recalling firm: Ethicon Endo-Surgery Inc
Product: FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065.
Product code: HET Laparoscope, Gynecologic (And Accessories)
Reason for recall: A defective articulation band may result in improper staple formation with possible hematosis.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot Numbers: T4VX78, T4WK0G, T4WL8T, T4XH6P, T4Y96L.

Product code HET

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)