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
Check against the official notice below — it lists the full affected range.
Maquet Cardiopulmonary has recalled certain aortic arterial cannulas (22 Fr, 23 cm length, part number 701002246) used in cardiopulmonary bypass procedures. The cannulas from lots 92181729 and 92181287 may have been supplied with de-airing plugs that could break when removed from the device. A total of 470 units were distributed worldwide, including to the United States, Puerto Rico, Australia, and numerous other countries.
The source does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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, Sl Quantity: 470 US Lot/code info: UDI CODE: 04037691123813, Lot Number: 92181729 and 92181287
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.