• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Smart Perfusion Pack

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Smart Perfusion Pack
see related information
Date Posted March 12, 2010
Recall Status1 Terminated on March 15, 2010
Recall Number Z-1088-2010
Recall Event ID 54250
Premarket Notification
510(K) Number
K881330 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Smart Perfusion Pack, REF: 088500700, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
Code Information Lot Numbers: 0923000063, 0930100038, and 0923600036.
Recalling Firm/
Manufacturer
Sorin Group USA, Inc.
14401 W 65th Way
Arvada, Colorado 80004
Manufacturer Reason
for Recall
Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.
Quantity in Commerce 57 units
Distribution AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = COBE LABORATORIES, INC.
-
-