Events

Recall of Device Recall 60 mL Syringe w/Lateral Flow Needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mallinckrodt Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61187
  • Event Risk Class
    Class 2
  • Event Number
    Z-1122-2012
  • Event Initiated Date
    2012-02-10
  • Event Date Posted
    2012-02-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107525
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Injection and syringe, angirgraphic - Product Code DXT
  • 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.
  • 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.

Device

Device Recall 60 mL Syringe w/Lateral Flow Needle
  • Model / Serial
    Catalog #: 801801; Lot #: 0008414, 0008415, 0015042, 0015043, 0022236, 0029499, 0029500, 0036252, 0036253, 0060075, 0064356, 0067043, 0071245, 0074027, 0078240, 0081116, 0085386, 0088170, 0095186, 0099109, 0102058, 0106079, 0109044, 0113426, 0120272, 0120472, 0123066, 0134341, 0141207, 0155153, 0155154, 0162123, 0235010, 0235011, 0246196, 0246197, 0260208, 0260209, 0300141, 0300142, 0309197, 0309198, 0316143, 0316144, 0316145, 0323181, 0337129, 0337130, 1007198, 1007199, 1007200, 1007201, 1021246, 1028228, 1028229, 1028230, 1028231, 1028232, 1035285, 1035286, 1035287, 1035288, 1042122, 1042123, 1049310, 1049311, 1049312, 1049313, 1056021, 1056022, 1063219, 1063220, 1070128, 1070129, 1084125, 1084126, 1091216, 1091217, 1098211, 1098212, 1105219, 1105220, 1119061, 1119062, 1119063, 1119064, 1147187, 1147188, 1154167, 1154168, 1217151, 1224177, 1231123, 1231124, 1238134, 1252133, 1252134, 1266175, 1266176, 1273129, 1273130, 1280130, 1280131, 1287134, 1287135, 1294121, 1294122, 1301131, 1301132, 1308138, 1315138, 1315139, 1322137, 1336335, 1336336, 1343177, 9023166, 9037138, 9037139, 9044170, 9044184, 9051152, 9051153, 9058256, 9058257, 9065164, 9065165, 9065448, 9072267, 9079179, 9079180, 9093273, 9093274, 9100261, 9100262, 9114150, 9114151, 9128089, 9128090, 9156194, 9156195, 9163187, 9163188, 9176144, 9176145, 9191020, 9191021, 9219142, 9219143, 9240131, 9240132, 9247098, 9247099, 9253017, 9253018, 9275101, 9275102, 9281033, 9281034, 9295029, 9295030, 9310048, 9310049, 9317055, 9317056, 9331148, 9331149, 9334065, 9338345, 9351119, 9352231, 9357639
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Mallinckrodt Inc

Manufacturer

Mallinckrodt Inc
  • Manufacturer Address
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA