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.
- Company
- Cardiac Assist, Inc
- Recall Initiated
- December 2, 2010
- Posted
- January 10, 2011
- Terminated
- December 1, 2011
- Recall Number
- Z-0889-2011
- Quantity
- 164
- Firm Location
- Pittsburgh, PA
Reason for Recall
Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications
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.
Lot / Code Info
Part number 5140-6221 - Lot numbers 2010060684 & 2010071887
Root Cause
Other
Action Taken
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.