FDA Device recall Z-2147-2016
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae…
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae… by Sorin Group Usa, citing sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2147-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-22 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sorin Group Usa |
| Distribution | US |
Product
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
Reason
Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
Identifiers
| code_info | Lots: 1505600017 ; 1505600018 ; 1506500005 ; 1509200078 ; 1513100112 ; 1513900027 ; 1513900028 ; 1514700045 ; 151660019…Lots: 1505600017 ; 1505600018 ; 1506500005 ; 1509200078 ; 1513100112 ; 1513900027 ; 1513900028 ; 1514700045 ; 1516600192 ; 1516800126 ; 1517800004 ; 1519500037 ; 1520100049 ; 1520100050 ; 1520900031 ; 1520900033 ; 1521600126 ; 1523000093 ; 1523600120 ; 1525100023 ; 1525800026 ; 1526500032 ; 1526500033 ; 1526500034 ; 1526500072 ; 1527200050 ; 1527200051 ; 1527200052 ; 1527800163 ; 1529300026 ; 1529300027 ; 1529300028 ; 1533500033 ; 1534200034 ; 1601900027 ; 1601900028 ; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2016%22
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