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.
Recall
- Recall Number
- Z-0641-2012
- Event Number
- 60462
- Firm
- Covidien, PLC
- FEI Number
- 1717344
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 4, 2011
- Posted
- January 11, 2012
- Terminated
- March 22, 2013
- Address
- 5920 Longbow Dr, Boulder, CO, 80301-3202
Description
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.
Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching.
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: [email protected], 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 [email protected] 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
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.
20,190 units