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U.S. Department of Health and Human Services

Class 2 Device Recall FlexTrayTM Endopath Cholecsystectomy Tray

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 Class 2 Device Recall FlexTrayTM Endopath Cholecsystectomy Traysee related information
Date Initiated by FirmDecember 15, 2004
Date PostedApril 27, 2005
Recall Status1 Terminated 3 on May 30, 2012
Recall NumberZ-0728-05
Recall Event ID 30727
Product Classification Instrument, Manual, Surgical, General Use - Product Code MDM
ProductFlexTrayTM Endopath Cholecsystectomy Tray, Kit code FDC21
Code Information V4206M, V42863, V42Y5T, V4351F.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information ContactCarol 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
ActionThe recalling firm sent letters to hospitals and distributors, dated 12/14/04.
Quantity in Commerce324 devices.
DistributionThe 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 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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