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 Recall Z-0193-2010 · Posted 2009-11-13
Advertisement
Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeKFM
Date Initiated2009-09-25
Date Terminated2009-12-14
Product Quantity256 units
Reason for Recall
A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.
Firm 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.
Root Cause
Packaging change control
Distribution Pattern
Worldwide Distribution -- US, Canada, Japan, and Europe.
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.
Advertisement