Events

Recall of Device Recall CryoPatch SG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CryoLife, 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
    67182
  • Event Risk Class
    Class 2
  • Event Number
    Z-0809-2014
  • Event Initiated Date
    2013-11-22
  • Event Date Posted
    2014-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124885
  • 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
    Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
  • Action
    CryoLife sent an Urgent Human Tissue Recall letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CryoLife to arrange for the return of the affected product. If the affected product had been implanted or discarded, customers should provide information regarding the status of the affected product on the attached self-addressed postcard. Customers with questions were instructedto contact the Field Assurance Department at 800-438-8285. For questions regarding this recall call 770-419-3355.

Device

Device Recall CryoPatch SG
  • Model / Serial
    Serial No. 10119759, Model SGPH00
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US distribution in CA.
  • Product Description
    Pulmonary Hemi-Artery SG || Used in heart surgery
  • Manufacturer
    CryoLife, Inc.

Manufacturer

CryoLife, Inc.
  • Manufacturer Address
    CryoLife, Inc., 1655 Roberts Blvd Nw, Kennesaw GA 30144-3632
  • Manufacturer Parent Company (2017)
    Cryolife Inc.
  • Source
    USFDA