Recall Z-0640-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien, PLC
LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Road, Shanghai 201114, P.R. Chin., Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatic
| Date | Jan 11, 2012 (initiated Nov 4, 2011) |
| Status | Terminated |
| Reason | Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching. |
| Root 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 |
| Quantity | 100,620 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, Lithuani |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031011 | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 Valleylab, Inc., May 29, 2003 |