Endopath EZ45 Endoscopic Linear Cutter (EZ45B)
- Company
- Ethicon Endo-Surgery
- Recall Initiated
- November 21, 2004
- Posted
- February 1, 2005
- Terminated
- October 29, 2008
- Recall Number
- Z-0457-05
- Quantity
- 3179 devices.
- Firm Location
- Cincinnati, OH
Reason for Recall
The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.
Distribution
The product was distributed to hospitals and distributors throughout the United States and to foreign customers located in Korea, China, Republic of Singapore, Argentina, Italy, New Zealand, Austria, Canada, Australia, Brazil, United Arab Emirate, Thailand, Czech Republic, Sweden, Switzerland, Greece, Russia, India, Portugal, Israel, Poland, Hungary, and Uruguay.
Lot / Code Info
EZ45B: lots T4XE79, T4XF7F, V40043, V40378, V40379, V4080M, V4083P, V40C1U, V40H0Y, V40K5V, V40W6T, V40X9X, V41831, V4197Y, V41A4M, V41C3Z, V41C98, V41E71, V41F9Y, V41U9F, V41Y80, V42105, V42220, V4231R, V4262Z, V4270F, V42C7P, V42G1X, V42K0X, V42MOT, V42P6P, V42V2R, V42Y1J, V42Z8Z, V43231, V43521, V4ZE36, V4ZE39, V4ZJ35, V4ZK34, V4ZV7W, V4ZX2N.
Root Cause
Other
Action Taken
The firm sent letters, dated 11/21/04, to all consignees.