Events

Recall of Device Recall HEMASHIELD Knitted Double Velour Cardiovascular Fabric

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GETINGE US SALES 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
    79536
  • Event Risk Class
    Class 2
  • Event Number
    Z-1172-2018
  • Event Initiated Date
    2018-01-03
  • Event Date Posted
    2018-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162603
  • 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
    Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
  • Reason
    A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.E. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
  • Action
    On January 3, 2018 an URGENT MEDICAL DEVICE RECALL NOTICE was issued to the (1) affected customer. A return authorization was issued with the recall letter, which is intended to be returned to the recalling firm. Questions or concerns can be directed to 1-800-528-7486

Device

Device Recall HEMASHIELD Knitted Double Velour Cardiovascular Fabric
  • Model / Serial
    UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    FL
  • Product Description
    HEMASHIELD Knitted Double Velour Cardiovascular Fabric
  • Manufacturer
    GETINGE US SALES LLC

Manufacturer

GETINGE US SALES LLC
  • Manufacturer Address
    GETINGE US SALES LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA