FDA Device recall Z-2159-2018
Aortic Arterial Cannula 20 Fr (O.D.)
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of Aortic Arterial Cannula 20 Fr (O.D.) by Maquet Cardiopulmonary Ag, citing this lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2159-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-14 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Maquet Cardiopulmonary Ag |
| Distribution | PR, VA |
Product
Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
Reason
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
Identifiers
| code_info | UDI CODE: 04037691085555, Lot Number: 92196585 |
|---|
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-2159-2018%22
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