Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Hazard
Identification of excess plastic on the tip of the cannula.
What You Should Do
Remedy
LivaNova sent an Urgent Medical Device letter dated June 16, 2017 to affected customers via certified mail or e-mail. The letter identified the affected product, problem and actions to be taken. The notice instructs customers to remove all recalled product from inventory and contact LivaNova Customer Support at 800-650-2623 to arrange for product return and replacement.
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Products
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile
Product Usage:
The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypas
- Brand
- Sorin Group USA, Inc.
- UPC
- Model No. NA-1116, NA-1118, NA-1126, NA-1136, NA-1206, NA-1207, NA-1208, NA-1316, NA-1327, NA-1337, NA-1338, RA-1117, RA-1126, RA-1127, RA-1128A, RA-1136, RA-1137A, RA-1137, RA-1138, RA-1206; Lot No. 1407000078 to 1705200165, S140979 to S141841.
Units Affected
105,770 units