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U.S. Department of Health and Human Services

Class 2 Device Recall FlexTrayTM Endopath Gastric Tray

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  Class 2 Device Recall FlexTrayTM Endopath Gastric Tray see related information
Date Initiated by Firm December 15, 2004
Date Posted April 27, 2005
Recall Status1 Terminated 3 on May 30, 2012
Recall Number Z-0756-05
Recall Event ID 30727
Product Classification Instrument, Manual, Surgical, General Use - Product Code MDM
Product FlexTrayTM Endopath¿ Gastric Tray, Kit Code TNG42.
Code Information V41T26, V42201, V42R3P, V42X4C, V4322J.
Recalling Firm/
Manufacturer
Ethicon Endo-Surgery
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Carol Montandon
513-337-3419
Manufacturer Reason
for Recall
Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.
FDA Determined
Cause 2
Other
Action The recalling firm sent letters to hospitals and distributors, dated 12/14/04.
Quantity in Commerce 90 devices.
Distribution The devices were distributed to hospitals and distributors located throughout the United States and to foreign consignees located in Saudi Arabia, Austria, Egypt, United Kingdom, Germany, France, Lebanon, The Netherlands, Spain, Pakistan, South Africa, Italy, United Arab Emirate, Czech Republic, Sweden, Switzerland, Greece, India, Portugal, Slovenia, Hungary, Palestine, and Kuwait.
Total Product Life Cycle TPLC 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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