| Class 2 Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly | |
Date Initiated by Firm | December 02, 2010 |
Date Posted | January 10, 2011 |
Recall Status1 |
Terminated 3 on December 01, 2011 |
Recall Number | Z-0889-2011 |
Recall Event ID |
57414 |
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 PA 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 | Other |
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 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 = DWF
|
|
|
|