Class 2 Device Recall Angiomat Illumena Syringe, 150mL Linden Luer Syringe with HandiFil Straw (p/n 900103)

• Date Initiated by Firm: May 20, 2011
• Date Posted: July 21, 2011
• Recall Status: Terminated on February 19, 2013
• Recall Number: Z-2859-2011
• Recall Event ID: 59103
• 510(K)Number: K963071
• Product Classification: Injection, contrast medium, automatic - Product Code IZQ
• Product: Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.
• Code Information: Lot number - 0253304, Part No. 900103
• Recalling Firm/ Manufacturer: Mallinckrodt Inc; 2111 E Galbraith Rd; Cincinnati OH 45237-1624
• For Additional Information Contact: 513-948-5719
• Manufacturer Reason for Recall: Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.
• FDA Determined Cause: Other
• Action: COVIDIEN sent an Urgent Device Recall letter dated May 20, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use the attached business response form and report the quantity of lot number 0253304 currently in their stock. If the customer did not have any of the affected lot they were to indicate by checking the appropriate box on the form. When completed, customers were asked to fax to (314) 654-8206 or email to productmonitoringhazelwood@covidien.com. All product from lot number 0253304 was to be returned to Covidien. Once the business notification form is received a Return Goods Authorization for the quantity of product reported will be sent to the customer. Customers would receive credit for all return product from affected lot. For any questions regarding this recall customers were asked to contact the Product Monitoring department at 800-778-7898. For questions about credit for the product, call Customer Service at 888-744-1414, menu option 1, and then menu option 2.
• Quantity in Commerce: 11,000 units (200 cases/50 units per case)
• Distribution: Worldwide Distribution - USA including CA, FL, IL, IN, MI, MO, NY, OH, TN & TX. and the country of Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZQ