CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascend

FDA device recall Z-1842-2012 · posted 2012-06-20 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. 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 parti

Action taken

Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advises customers to discontinue use of the affected product and to return the product to the firm. A Response Form was attached for customers to complete and return. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DWF

Quantity affected

133,793 (each)

Distribution

Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ

Date initiated

2012-05-09

Date posted

2012-06-20

Date terminated

2013-07-11

Location

Ann Arbor, MI

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