Recall Z-0192-2010 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Sorin Group USA, Inc.
Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***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.
| Date | Nov 13, 2009 (initiated Sep 25, 2009) |
| Status | Terminated |
| Reason | A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility. |
| Root cause | Packaging change control |
| Action | 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. |
| Quantity | 808 units |
| Distribution | Worldwide Distribution -- US, Canada, Japan, and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011835 | COBE REVOLUTION Cobe Cardiovascular, Inc., Feb 12, 2002 |