Class 2 Device Recall Illumena 150mL Linden Luer Syringe (p/n 900103) & Illumena 150mL Regular Luer Syringe (p/n 900101)

• Date Initiated by Firm: October 11, 2011
• Date Posted: January 20, 2012
• Recall Status: Terminated on July 19, 2013
• Recall Number: Z-0830-2012
• Recall Event ID: 60874
• 510(K)Number: K781334
• Product Classification: Injector, contrast medium, automatic - Product Code IZQ
• Product: Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are 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.
• Code Information: Catalog # 900103 - Lot # 0253304, Exp Date. 09/2013; Lot # 0298222, Exp Date 10/2013; Lot # 0298223, Exp Date 10/2013; Lot # 0308031, Exp Date 11/2013; Lot # 0312202, Exp Date 11/2013; Lot # 0330293, Exp Date 11/2013; Lot # 0344197, Exp Date 12/2013; Lot # 0351244, Exp Date 12/2013; Lot # 0351245, Exp Date 12/2013; Lot # 1007208, Exp Date 01/2013; Lot # 1014335, Exp Date 01/2013; Lot # 1126136, Exp Date 05/2013; Lot # 1175144, Exp Date 06/2013; Lot # 1189159, Exp Date 07/2013 & Lot # 1203154, Exp Date 07/2013. Catalog # 900101 - Lot #, 0314042, Exp Date, 11/2013; Lot #, 0323224, Exp Date, 11/2013; Lot #, 0356041, Exp Date, 12/2013; Lot #, 1007265, Exp Date, 01/2013; Lot #, 1119054, Exp Date, 04/2013 & Lot #, 1133140, Exp Date, 05/2013.
• 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 Illumena 150mL Syringe with Handi-Fil Straw, product 900101.
• FDA Determined Cause: Packaging
• Action: The firm, Covidien, sent an "URGENT DEVICE RECALL" letter dated October 11, 2011 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to check their inventory, if any of the affected lots are found, discontinue use of the lots immediately; complete and return the BUSINESS RESPONSE FORM even if they do not have any of the affected lots via fax to (314) 654-8206 or email to imaging.recalls@covidien.com by October 28, 2011; return product and notify any consignees that this product may have been distributed to. If you have any questions about this recall, contact our Product Monitoring department at 800-778-7898.
• Quantity in Commerce: 187,400 units (900103 syringe: 129,200; 900101 syringe: 58,200)
• Distribution: USA (nationwide) including states of: AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV; and countries of: Australia, Belgium, Brazil, Canada, Singapore, & Uruguay.
• 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