Events

Recall of Tenaxis Medical ArterX(TM) Surgical Sealant

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

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
    77482
  • Event Risk Class
    Class 2
  • Event Number
    Z-2687-2017
  • Event Initiated Date
    2014-10-17
  • Event Date Posted
    2017-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156110
  • 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
    Sealant,polymerizing - Product Code NBE
  • Reason
    Product was improperly labeled leading to improper storage.
  • Action
    The direct consignee was notified by email on October 17, 2014. The action requested to be taken on receipt of the notice: " Remove all ArterX delivered by CJ Medical from inventory and quarantine for return to CJ Medical. " Return the product to CJ Medical for a credit or product replacement " If no ArterX is found in inventory, please comment to that effect on the attached form and return the form to CJ Medical. The consignee was also requested to circulate the Field Safety Notice among all users affected by this product. For further questions, please call (314) 654-2000.

Device

Tenaxis Medical ArterX(TM) Surgical Sealant
  • Model / Serial
    Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution to the country : UK
  • Product Description
    Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC || Adjunct to sutures in vascular surgery.
  • Manufacturer
    Mallinckrodt Manufacturing LLC

Manufacturer

Mallinckrodt Manufacturing LLC
  • Manufacturer Address
    Mallinckrodt Manufacturing LLC, 835 Maude Ave, Mountain View CA 94043-4021
  • Manufacturer Parent Company (2017)
    Mallinckrodt Plc
  • Source
    USFDA