RecallRadar

FDA Device recall Z-2161-2018

Aortic Arterial Cannula 24 Fr (O.D.)

On 2018-06-20 the FDA classified a Class II recall of Aortic Arterial Cannula 24 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

AgencyFDA Device
Recall numberZ-2161-2018
ClassificationClass II
Statusterminated
Initiated2018-05-14
Published2018-06-20
Last updated2026-09-13 11:54 UTC
CompanyMaquet Cardiopulmonary Ag
DistributionPR, VA

Product

Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. 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_infoUDI CODE: 04037691239804, Lot Number: 92180017, 92183437 and 92184278

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-2161-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.