Recall Z-2859-2011 ยท IZQ Injector, Contrast Medium, Automatic
Mallinckrodt Inc
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
| Date | Jul 21, 2011 (initiated May 20, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963071 | ANGIOMAT ILLUMENA Mallinckrodt Inc., Liebel-Flarsheim Business, Sep 23, 1997 |