Events

Recall of Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thomas Medical Products 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
    57679
  • Event Risk Class
    Class 2
  • Event Number
    Z-1227-2011
  • Event Initiated Date
    2010-12-16
  • Event Date Posted
    2011-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96995
  • 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
    vascular interventional device - Product Code DYB
  • Reason
    Compromised sterility/weak or open seals.
  • Action
    GE Healthcare Thomas medical products Recall notification dated 16 December 2010 (GEHC Ref # 35003) was sent by letter via UPS Next Day Air and/or USPS certified mail.

Device

Device Recall Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve
  • Model / Serial
    SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09, Lot #S32071; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826, Lot #S32067; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S32830; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S33028; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S33050; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07, Lot #S33628; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09, Lot #S32206; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195, Lot No. S32546.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution Nationwide USA and Germany.
  • Product Description
    Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195.
  • Manufacturer
    Thomas Medical Products Inc

Manufacturer

Thomas Medical Products Inc
  • Manufacturer Address
    Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
  • Source
    USFDA