LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a divisio

FDA device recall Z-0640-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Covidien, PLC

Reason for recall

Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GEI

Quantity affected

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,

Date initiated

2011-11-04

Date posted

2012-01-11

Date terminated

2013-03-22

Location

Boulder, CO

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