FDAFDA · Food and drugs·Recall number Z-1880-2012
INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
Published July 4, 2012 · Recall initiated: May 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- Worldwide Distribution - US (nationwide) including the states of: AL, AR , AZ , CA, CT , FL, IA , IL, IN , KS , LA , MI , NM, MO , NC, NE , NJ , NV, NY , OH, OK , PA, RI , SC , TN, TX, WA , WI, WV and the countries of: BELGIUM, BRAZIL, Byelorussian SSR, CAMBODIA , Dominican Republic, Honduras, Japan, Malaysia, Mexico, Nicaragua, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, UNITED ARAB EMIRATES (UAE), and Vietnam.
- Lot
- Catalog number: 71415-03 and lot numbers: NC21, NF16, NL26, PA30,PC13, and PD05.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.