MAYO MN XCOATED 3/8X1/2 AV 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.
Enforcement
- Recall Number
- Z-1885-2012
- Event ID
- 61731
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 4, 2012
- Initiation Date
- May 9, 2012
- Classification Date
- June 27, 2012
- Termination Date
- April 24, 2013
- Address
- 6200 Jackson Road, Ann Arbor, MI, 48103-9586, United States
Description
MAYO MN XCOATED 3/8X1/2 AV 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.
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
Catalog number: 73395 and lot number: MK30 and MK30T
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.
53,139 (each) in total