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Recall Observatory FDA recall evidence

Device product

Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass

Z-2160-2018

May 14, 2018

Class II

Product summary

Firm
Maquet Cardiopulmonary Ag
Event
Event 80076
Status
Terminated
Classification
Class II
Quantity
470 US
Official record key
device-enforcement:Z-2160-2018

Official wording

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.

Code information: UDI CODE: 04037691123813, Lot Number: 92181729 and 92181287

Distribution pattern: Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.