Events

Recall of Device Recall CAPIO, Monodeck

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

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
    67973
  • Event Risk Class
    Class 2
  • Event Number
    Z-1534-2014
  • Event Initiated Date
    2014-03-11
  • Event Date Posted
    2014-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126705
  • 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
    Suture, surgical, absorbable, polydioxanone - Product Code NEW
  • Reason
    The product did not meet minimum and/or average minimum teleflex resorption strength requirements.
  • Action
    Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 11, 2014. The letter identified the affected product, problem and actions to be taken. Custmers were instructed to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990

Device

Device Recall CAPIO, Monodeck
  • Model / Serial
    Product Code: 833-137, Lot numbers: 02A0901938, 02B0901537, 02H1001025, 02H1001026, 02H1001027, 02C1102979, 02C1102983, 02D1300294, 02D1301164, 02C1302078, 02D1302468.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.
  • Product Description
    CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA