Terminated

Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 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.

FDA Recall Z-1122-2012 · Posted 2012-02-29

Recall StatusTerminated

Product CodeDXT

Date Initiated2012-02-10

Date Terminated2013-12-24

Reason for Recall

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.

Firm 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 [email protected] or fax to 888-257-7910. For any questions customers should call 866-761-9571.

Root Cause

Packaging process control

Distribution Pattern

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, Puerto Rico and the countries of Canada, Australia, Belgium, Brazil, Chile, Ecuador, Guatemala, Mexico, Panama, Singapore, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984088OPTISTAR MR INJECTOR SYSTEMMallinckrodt Inc., Liebel-Flarsheim Business · 1999-12-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.