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U.S. Department of Health and Human Services

Class 2 Device Recall 25 mL Sryinge with lateral flow needle.

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  Class 2 Device Recall 25 mL Sryinge with lateral flow needle. see related information
Date Initiated by Firm February 10, 2012
Date Posted February 29, 2012
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-1119-2012
Recall Event ID 61187
510(K)Number K984088  
Product Classification Injection and syringe, angirgraphic - Product Code DXT
Product Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt, 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.
Code Information Catalog #: 801103; Lot #s: 0060074, 0102055, 0218191, 1063215, 9281040.
Recalling Firm/
Mallinckrodt Inc
2111 E Galbraith Rd
Cincinnati OH 45237-1624
For Additional Information Contact Dirk Stevens, Ph.D.
Manufacturer 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.
FDA Determined
Cause 2
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 covidien2600@stericycle.com or fax to 888-257-7910. For any questions customers should call 866-761-9571.
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, Puerto Rico and the countries of Canada, Australia, Belgium, Brazil, Chile, Ecuador, Guatemala, Mexico, Panama, Singapore, and 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 = DXT and Original Applicant = MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS