—#85828

Product

Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog# 050300700***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th way Arvada (CO) 80004-3599" Intended for use in cardiopulmonary bypass procedures.

FDA product code: KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K030462
Affected lot / code info: Lot number: 0905220164.

Why it was recalled

A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.

Root cause (FDA determination)

Packaging change control

Action the firm took

Customers were notified by an Urgent: Field Safety Notice, dated 9/25/09, and instructed to: check their inventory for the affected product, complete the customer response form and return or visually inspect all affected product before use. For additional information contact 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 -- US, Canada, Japan, and Europe.

Timeline

Recall initiated: 2009-09-25
Posted by FDA: 2009-11-13
Terminated: 2009-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85828. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.