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Ethicon Endo-Surgery Inc recalls Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved di
Recalled July 31, 2013 · FDA recall Z-1772-2013 · Ethicon Endo-Surgery
Hazard
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. · FDA Class II
Units
327,648 instruments
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Ethicon Endo-Surgery Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →