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
Check against the official notice below — it lists the full affected range.
Maquet Cardiopulmonary is recalling a specific lot of Aortic Arterial Cannula (20 Fr, 23 cm length with 3/8-inch wide connector, Part Number 701002206) used in cardiopulmonary bypass procedures. The cannulas in this lot may have been supplied with 3/8-width de-airing plugs that could break when being removed from the device.
The affected lot (Number 92196585, UDI CODE 04037691085555) consisted of 40 units distributed worldwide, including to the U.S. states and territories of Virginia and Puerto Rico, plus numerous international locations. The source document does not specify a remedy for consumers affected by this recall.
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: 40 US Lot/code info: UDI CODE: 04037691085555, Lot Number: 92196585
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.