—#87091

Product

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 product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K003587
Affected lot / code info: Lot Numbers: 0911800018, 0913100047, 0914600040, 0918700001, 0918700209, 0920100039, 0921500032, 0925100121, 0927200001, 0928600055, 0930100007.

Why it was recalled

Vessel clamping device may break during use.

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004

Distribution

Distribution pattern: Worldwide Distribution -- United States, Australia, Canada and Italy.

Timeline

Recall initiated: 2009-11-25
Posted by FDA: 2010-01-14
Terminated: 2010-10-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87091. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.