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.
- Company
- Mallinckrodt Inc
- Recall Initiated
- October 11, 2011
- Posted
- January 20, 2012
- Terminated
- July 19, 2013
- Recall Number
- Z-0830-2012
- Quantity
- 187,400 units (900103 syringe: 129,200; 900101 syringe: 58,200)
- Firm Location
- Cincinnati, OH
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.
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.
Lot / Code Info
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.
Root Cause
Packaging
Action Taken
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.