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U.S. Department of Health and Human Services

Class 2 Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter

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 Class 2 Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cuttersee related information
Date Initiated by FirmNovember 25, 2003
Date PostedDecember 17, 2003
Recall Status1 Terminated 3 on May 09, 2012
Recall NumberZ-0216-04
Recall Event ID 27763
Product Classification Instrument, Ultrasonic Surgical - Product Code LFL
ProductFlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24.
Code Information Lot Numbers: T4VZ68, T4W30K, T4W881, T4WL7Z, T4WR5X, T4WT38, T4WY34, T4X38G, T4X52L, T4YC9J.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information ContactMr. 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
ActionThe firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
Quantity in Commerce411
DistributionThe product was shipped to hospitals and distributors located nationwide and worldwide.
Total Product Life CycleTPLC Device Report
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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