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U.S. Department of Health and Human Services

Class 2 Device Recall Revolution Blood Pump with PC Coating

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  Class 2 Device Recall Revolution Blood Pump with PC Coating see related information
Date Initiated by Firm September 25, 2009
Date Posted November 13, 2009
Recall Status1 Terminated 3 on December 14, 2009
Recall Number Z-0193-2010
Recall Event ID 53543
510(K)Number K030462  
Product Classification Nonroller-Type Cardiopulmonary Bypass Blood Pump - Product Code KFM
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.
Code Information Lot number: 0905220164.
Recalling Firm/
Manufacturer		 Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004
For Additional Information Contact
800-650-2623
Manufacturer Reason
for Recall		 A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.
FDA Determined
Cause 2		 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 in Commerce 256 units
Distribution Worldwide Distribution -- US, Canada, Japan, and Europe.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KFM and Original Applicant = COBE CARDIOVASCULAR, INC.
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