Sorin / Clearglide Precision Bipolar, REF PBD01, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall Z-0630-2010 · Posted 2010-01-14
Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2009-11-25
Date Terminated2010-10-04
Product Quantity756 units
Reason for Recall
Vessel clamping device may break during use.
Firm Action
Consignees were notified by "Urgent Field Safety Notice" dated November 24, 2009 with instructions to examine the device before, during and after use. Customers were instructed to not use the device, if it is damaged. Customers were also instructed to contact the Sorin Group Customer Service at 1-800-650-2623 to arrange shipment of replacement product and requested to complete and return the response form. Direct questions to the Sorin Group Customer Service at 1-800-650-2623.
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution -- United States, Australia, Canada and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.