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

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.

Urgent Medical Device Recall letters were distributed beginning 5/14/18. The letters instructed customers to do the following: 1. Read and understand this notification, and disseminate the information provided to all users, or prospective users, of the affected arterial cannulae. 2. Check your arterial cannula inventory and compare with the Getinge part number, article number and lot number provided on Page 1 of this notification. 3. Remove any affected product that are still in your inventory and prepare it for shipment back to Getinge. 4. Call Getinge Customer Support at 1-888-627-8383 (Press Option 2 and then Option 2) for a Return Authorization (RGA) and for shipping information and label. Customer Support will issue a credit for the product return. 5. Complete, sign and promptly return the filled out response form (Page 4 of this notification) either by email to [email protected] or by fax to 1-973-860-1675.