Events

Recall of Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath

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

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
    77661
  • Event Risk Class
    Class 2
  • Event Number
    Z-0228-2018
  • Event Initiated Date
    2017-06-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157346
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    An incomplete seal at the chevron end of the primary packaging of the glidesheath slender introducer sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). this breach of the sterile barrier may compromise the sterility of the sheath.
  • Action
    URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters (dated June 7, 2017) and Response Forms were sent to the consignees via UPS on June 7, 2017.

Device

Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath
  • Model / Serial
    Lot s 161115, 161130, 161207, 170116
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
  • Manufacturer
    Terumo Medical Corp

Manufacturer

Terumo Medical Corp
  • Manufacturer Address
    Terumo Medical Corp, 2101 Cottontail Ln, Somerset NJ 08873-1277
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA