Recall Z-2394-2008

Reason for recall

Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.

FDA-determined cause: Packaging process control

Action taken

Distributors and Retailers that have received any of the Catalog Numbers listed in the letter titled URGENT MEDICAL DEVICE RECALL were notified on/about July 17, 2008. Recipients of the letter are being requested to review their inventory and return any of the applicable Catalog Items from the specific lot numbers listed in the recall letter. Distributors are being instructed to notify their customers and inform them of the recall with a copy of the recall letter. Their notification should instruct their customers to return the recalled product to them so that they could return the product to Apogee Medical LLC. In addition to the initial letter, follow-up letters, telephone calls and emails will be utilized to assess the effectiveness of the recall. A spreadsheet has been set up and will be maintained in order to easily identify the customers that have been contacted, those who have responded and those who have returned product. If you have questions, contact Diane Peper at 919-435-5409.