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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Event Detail

Event ID 65330
Product Type Devices
Status Ongoing
Recalling Firm Ethicon Endo-Surgery Inc
City Cincinnati
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - US Nationwide all fifty states and including the countries of Canada, Belgium, India, Malaysia, Saudi Arabia, Brazil, Israel, Mexico, Singapore, Jordan, New Zealand, Taiwan, Chile, Korea, Puerto Rico, Turkey, Columbia, Kuwait, Qatar, United Arab Emirates, Egypt, Lebanon and Russia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments'¬" lock-out feature is designed to prevent a used reload from being refired. The following lot numbers and associated expiration dates are affected by this recall: J4AY8Z 5/15/2013, J4C00J 6/15/2013, J4C87R 7/15/2013, J4CC1F 8/15/2013, J4CD2X 8/15/2013, J4CF3D 9/15/2013, J4CJ0E 9/15/2013, J4CJ78 9/15/2013, J4CK2P 9/15/2013, J4CM9X 10/15/2013, J4CR2H 10/15/2013, J4CT5H 11/15/2013, J4CU86 11/15/2013, J4CV1W 11/15/2013, J4CV5H 11/15/2013, K4C149 12/15/2013, K4C17W 12/15/2013, K4C33U 12/15/2013, K4C41C 12/15/2013, K4C600 1/15/2014, K4C64A 1/15/2014, 4C728 1/15/2014, K4C82K 1/15/2014, K4C88F 1/15/2014, K4C94W 1/15/2014, K4CC0L 2/15/2014, CC8L 2/15/2014, K4CD1E 2/15/2014, K4CF1P 2/15/2014, K4CF5D 2/15/2014, K4CG18 3/15/2014, K4CG4J 3/15/2014, K4CG8P 3/15/2014, K4CH44 3/15/2014, K4CK0W 3/15/2014, Class II Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence. 57,540 Units Z-1530-2013