Recall Z-2866-2011

Reason for recall

Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "Important Product Use Reminder" to remind users of proper procedures for using the system and the need for diligence in reducing air embo

FDA-determined cause: Device Design

Action taken

Medrad Inc., sent two types of "MEDICAL DEVICE FIELD CORRECTION" notifications on June 2, 2011 to all affected customers. 1. To those customers who Avanta Systems have already undergone market withdrawal and thus have been upgraded, the notification provided customer awareness that prior action should be considered a field correction. The letter stated that NO action is required since their system(s) has already been upgraded. If you have any questions, concerning these activities contact the Director of Quality Systems at (724) 940-6905. 2. To those customers whose Avanta Systems have not yet been upgraded through market withdrawal, the notification informed customers that the recalling firm is undertaking a Field Correction to upgrade their system(s). The letter included a step by step guide that will allow customers to verify that their system(s) has NOT been upgraded. Customers are instructed to complete and fax this form to MEDRAD at (412) 406-0941. If you have any questions, concerning these activities contact the Product Manager at (412) 767-2400, extension 8401.