Class 2 Device Recall LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider

• Date Initiated by Firm: November 04, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on March 22, 2013
• Recall Number: Z-0641-2012
• Recall Event ID: 60462
• 510(K)Number: K031011
• Product Classification: LigaSure V 5 mm Dolphin Tip Laparoscopic - Product Code GEI
• Product: LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleylab a division of Tyco Healthcare Group LP, Boulder, CO 80301, Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Rd., Shanghai 201114, P.R. China.; ; Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
• Code Information: Lot numbers: S1CB010X, S1CB011X, S1DB001X, S1DB002X, S1EB012P, S1EB013P, S1EB014P, S1FB031PX, S1FB032PX, S1FB033PX, S1FB035X, S1FB036X, S1FB037X, S1FB038X, S1FB039X, S1FB049X, S1FB050X, S1FB051X, S1GB005X, S1GB006X, S1GB007X, S1HB010, S1HB011, S1HB012, S1HB013P. S1CB001, S1CB002, S1CB003, S1CB004, S1CB005, S1CB006, S1CB007R, S1CB008X, S1CB009X, S1CB012RX, S1CB013PRX, S1CB014PRX, S1CB015PRX, S1CB016PRX, S1CB017PRX, S1CB018PRX, S1CB019PRX, S1CB020PRX, S1CB021PRX, S1CB022PRX, S1CB023PRX, S1CB024PRX, S1CB025PRX, S1DB006X, S1DB007X, S1DB008X, S1DB009X, S1DB010X, S1DB011X, S1DB012X, S1DB013X, S1DB014X, S1DB015X, S1DB016X, S1DB017X, S1DB018X, S1DB019X, S1DB020X, S1DB021X, S1DB022X, S1DB023X, S1EB001X, S1EB002X, S1EB003X, S1EB004X, S1EB005X, S1EB006X, S1EB007RX, S1EB008RX, S1EB009X, S1EB010RX, S1EB011RX, S1EB016P, S1EB017P, S1EB018P, S1EB019P, S1EB020P, S1EB021P, S1EB022P, S1EB023P, S1EB024P, S1EB025P, S1EB026P, S1EB027P, S1EB028P, S1EB029P, S1EB030P, S1EB031P, S1EB032P, S1EB033P, S1EB034P, S1EB035P, S1EB036P, S1EB037P, S1EB038P, S1EB039P, S1EB040P, S1EB041P, S1EB042P, S1FB001P, S1FB005PX, S1FB006PX, S1FB007PX, S1FB008PX, S1FB009PX, S1FB010PX, S1FB011PX, S1FB012PX, S1FB013PX, S1FB014PX, S1FB015PX, S1FB016PX, S1FB017PX, S1FB027PX, S1FB028PX, S1FB029PX, S1FB040X, S1FB041X, S1fb042X, S1FB043X, S1FB044X, S1FB045X, S1FB046X, S1FB047X, S1FB048X, S1FB052X, S1GB001X, S1GB002X, S1GB003x, S1GB004X, S1GB009X, S1GB010X, S1GB011X, S1GB012X, S1GB013X, S1GB014X, S1GB015X, S1GB016X, S1GB017X, S1GB018X, S1HB002, S1HB003, S1HN004, S1HB005, S1HB006, S1HB007, S1HB008, S1HB009P, S1HB014P, S1HB015P, S1HB016P, S1HB017P, S1HB018P, S1HB019, S1HB021X, S1HB022X, S1HB023X, S1HB024X, S1HB027PX, S1HB028PX, S1HB029PX, S1HB031X, S1HB032X, S1HB033X, S1JB034X, S1JB035X, S1JB036X, S1JB038PX, S1JB041X, S1JB042X, S1JB043X, S1JB044PX, S1JB045PX, S1JB046X, S1JB047X, S1JB048X.
• Recalling Firm/ Manufacturer: Covidien, PLC; 5920 Longbow Dr; Boulder CO 80301-3202
• For Additional Information Contact: 303-530-6227
• Manufacturer Reason for Recall: Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Covidien sent an Urgent Medical Device Recall letter dated November 9, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory, Complete the attached Recalled Product Return Form in its entirety. Fax the completed form to (203) 822-6009 and include a copy of the completed form with the products being returned. If customers did not have any units from the affected lots in their inventory, simply return the recall form, via fax or email to: SDFeedback@Covidien.com, indicating you have zero (0) units. If the affected product was purchased directly from Covidien, return product as follows: Customers should contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722-8772, option 1, to obtain a Return Goods Authorization (RGA) prior to returning the affected units. Covidien will arrange for shipment pickup and will cover all freight costs associated with the return. Ship affected products with the RGA # provided by Customer Service to: Covidien, Surgical Solutions Building 4/Receiving 5920 Longbow Drive Boulder, CO 80301 If the affected product was purchased from a distributor, customers should contact their distributor to obtain instructions for return of their affected product. Customers will receive a credit for all products returned. For questions call 303-530-6227
• Quantity in Commerce: 20,190 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatamala, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Netherlands, Norway, Oman, Panama, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Tunisia, Turkey, UAE, UK, and Vietnam.
• 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 = GEI and Original Applicant = VALLEYLAB, INC.