Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG 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.
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 You Should Do
Terumo sent an Urgent Medical Device Recall letter dated May 9, 2012 to All US first consignees will receive a removal notification letter via Federal Express. The letter identified the affected products, reason for correction and actions to be taken. Customers were instructed to discontinue use of affected products and return for replacement. The letter advised customers to assure that all users are aware of this notice and to fill out and return the attached Response Form. For questions call Terumo CVS Customer Service at 1-800-521-2818 or by fax at 1-800-292-6551.
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Products
- Brand
- Terumo Cardiovascular Systems Corporation
- UPC
- Catalog number: 203861: 0548731, 0552411, 0556018, 0558941, 0563005, 0565138, 0565841, 0569745, 0570058, 0571163, 0571584, 0573043, 0573288, 0575518, 0580832, 0583446,0585251, 0586160, 0590448, 0591942, 0596210, 0600490, 0607020, 0618429, 0619201, 0630155, 0634777, 0640509, 0649185, 0652212, 0655898, 0661142, and 0668560.
Units Affected
53,139 (each) in total