FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065.
FDA device recall Z-0224-04 · posted 2003-12-17 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery
- Reason for recall
- A defective articulation band may result in improper staple formation with possible hematosis.
- Action taken
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HET
- Quantity affected
- 45
- Distribution
- The product was shipped to hospitals and distributors located nationwide and worldwide.
- Date initiated
- 2003-11-25
- Date posted
- 2003-12-17
- Date terminated
- 2012-05-09
- Location
- Cincinnati, OH
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