FlexTrayTM Endopath Cholecsystectomy Tray, Kit Code TDC45.
- Company
- Ethicon Endo-Surgery
- Recall Initiated
- December 15, 2004
- Posted
- April 27, 2005
- Terminated
- May 30, 2012
- Recall Number
- Z-0744-05
- Quantity
- 12 devices.
- Firm Location
- Cincinnati, OH
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.
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.
Lot / Code Info
V42C9U.
Root Cause
Other
Action Taken
The recalling firm sent letters to hospitals and distributors, dated 12/14/04.