Recall Z-0830-2012 ยท IZQ Injector, Contrast Medium, Automatic
Mallinckrodt Inc
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 va
| Date | Jan 20, 2012 (initiated Oct 11, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root 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 ques |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K781334 | DISPOSABLE SYRINGE FILL TUBE Mallinckrodt Group, Inc., Aug 17, 1978 |