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U.S. Department of Health and Human Services

Class 2 Device Recall Endopath Electrosurgery Probe Plus II

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  Class 2 Device Recall Endopath Electrosurgery Probe Plus II see related information
Date Initiated by Firm April 08, 2013
Date Posted July 19, 2013
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-1772-2013
Recall Event ID 65504
510(K)Number K912492  
Product Classification Laparoscope, general; plastic surgery - Product Code GCJ
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Customer Support Center
877-384-4266
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Packaging
Action The firm, Ethicon Endo-Surgery, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 22, 2013 to all consignees/customers via overnight UPS to allow tracking of the receipt. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to do the following: EFFECTIVE IMMEDIATELY-DO NOT USE ANY OF THE FOLLOWING TWELVE (12) PRODUCT CODES within the noted Expiration Dates provide in the letter; examine your inventory immediately to determine if you have affected product on hand; remove the affected product; complete and return the Business Reply Form (BRF) and fax to: 1-888-912-7089 or email to: ees3118@stericycle.com within 3 business days, even if you do not have affected product; return affected product with a photocopy of the completed BRF; and share this information with all of the appropriate staff at your facility. If you need additional shipping labels or a communications package, contact the Stericycle's support center at 1-888-943-4896 and reference Event 3118. "Returned ENDOPATH Probe Plus II Shafts will be replaced with corrected ENDOPATH Probe Plus II Shafts once supply becomes available. If replacement product is not available and/or has been discontinued, a credit will be issue." If you need clinical or product support, please contact your local representative or call our Customer Support Center, 1-877-ETHICON (877-384-4266).
Quantity in Commerce 327,648 instruments
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = ETHICON, INC.
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