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
Product summary
- 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
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.