FDA Device recall Z-2871-2017
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 p…
- FDA Device
- Class II
- terminated
- Published 2017-08-16
On 2017-08-16 the FDA classified a Class II recall of 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 p… by Sorin Group Usa, citing identification of excess plastic on the tip of the cannula.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2871-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-09 |
| Published | 2017-08-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sorin Group Usa |
| Distribution | US |
Product
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.
Reason
Identification of excess plastic on the tip of the cannula.
Identifiers
| code_info | 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, R…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. |
|---|
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-2871-2017%22
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