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U.S. Department of Health and Human Services

Class 2 Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly

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 Class 2 Recall
TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly
see related information
Date Posted January 10, 2011
Recall Status1 Terminated on December 01, 2011
Recall Number Z-0889-2011
Recall Event ID 57414
Premarket Notification
510(K) Number
K052570 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
Code Information Part number 5140-6221 - Lot numbers 2010060684 & 2010071887
Recalling Firm/
Manufacturer
Cardiac Assist, Inc
240 Alpha Dr
Pittsburgh, Pennsylvania 15238-2906
For Additional Information Contact Andy Bishop
412-963-7770 Ext. 271
Manufacturer Reason
for Recall
Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action CardiacAssist, Inc. sent a Voluntary Recall letter dated November 12, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to examine inventory for the affected product and remove from inventory and identify it as a recalled product by applying the enclosed "CAUTION: DO NOT USE" sticker(s) and quarantine to prevent usage. Consignees were to complete the form included with the letter and fax a copy of the form to (412) 963-9739 to coordinate the return and replacement of any affected product. For questions regarding this recall call (412) 963-7770, ext. 271.
Quantity in Commerce 164
Distribution Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, 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 = CARDIAC ASSIST, INC.
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