Z-1118-2012

Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in...

Name: Z-1118-2012 Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in...
Creator: Mallinckrodt Inc
Published: 2012-02-10
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2012-02-10 / Terminated / root cause: packaging

FDA source

Mallinckrodt Inc began a recall of Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec... on 2012-02-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1118-2012
Status: Terminated
Initiated: 2012-02-10
Posted: 2012-02-29
Terminated: 2013-12-24
Recalling firm: Mallinckrodt, Inc.
Product: Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, 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.
Product code: DXT Injector And Syringe, Angiographic
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.
Root cause tag: packaging
FDA 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 [email protected] or fax to 888-257-7910. For any questions customers should call 866-761-9571.
Quantity in commerce: 665 Cases
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.
Product codes and lots: Catalog #: 801104; Lot #s: 0001110, 0067041, 0074024, 0130214, 0155164, 0162121, 0278106, 0344212, 0351225, 1021271, 1210163, 1336343, 9058252, 9121110, 9212120, 9260020, 9302042, 9317041

Product code DXT

K984088Class IIOptistar Mr Injector SystemMallinckrodt Inc., Liebel-Flarsheim Business / cleared 1999-12-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)