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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65504
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 2013-04-08
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, lA, ID, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and countries of: Canada, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Ecuador, Egypt, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Libya, Malaysia, Mexico, Pakistan, Panama, Philippines, Poland, Puerto Rico, Russia, Singapore, Slovenia, South Africa, Spain, Saudi Arabia, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Venezuela.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve. Product Code: EPS01, Exp. Date: 2015 09 through 2018 03; Product Code: EPS02, Exp. Date: 2015 09 through 2018 03; Product Code: EPS03, Exp. Date: 2015 09 through 2018 03; Product Code: EPS04, Exp. Date: 2015 09 through 2018 03; Product Code: EPS05, Exp. Date: 2015 09 through 2018 03; Product Code: EPS06, Exp. Date: 2015 09 through 2018 03; Product Code: EPS07, Exp. Date: 2015 09 through 2018 03; Product Code: EPS08, Exp. Date: 2015 09 through 2018 03; Product Code: EPS10, Exp. Date: 2013 04 through 2018 03; Product Code: EPS11, Exp. Date: 2013 04 through 2018 03; Product Code: EPS12, Exp. Date: 2013 04 through 2018 03 & Product Code: EPS13, Exp. Date: 2013 04 through 2018 03. Class II The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device. 327,648 instruments Z-1772-2013
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