Recall Z-1121-2012 ยท DXT Injector And Syringe, Angiographic
Mallinckrodt Inc
Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case. Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure.
| Date | Feb 29, 2012 (initiated Feb 10, 2012) |
| Status | Terminated |
| Reason | The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised. |
| Root cause | Packaging process control |
| Action | Covidien sent an Urgent Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product immediately. Customers were to use the attached business response form to report the quantity of each lot that is currently in their stock. If customers did not have any of these lots in stock, they should indicate by checking the appropriate box on the business report form. When completed, customers should email the completed form to |
| Distribution | Worldwide Distribution - USA including Distributed worldwide: USA including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, Puert |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984088 | OPTISTAR MR INJECTOR SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business, Dec 6, 1999 |