Events

Recall of Device Recall VenaFlow Calf Garment (Aircast)

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

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
    78714
  • Event Risk Class
    Class 2
  • Event Number
    Z-0272-2018
  • Event Initiated Date
    2017-12-01
  • 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=160214
  • 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
    Sleeve, limb, compressible - Product Code JOW
  • Reason
    3040 compression sleeves being mislabeled as a 3010-pl compression sleeves.
  • Action
    An Urgent Medical Device Recall letter, dated December 5, 2017, was distributed to customers. The letter described the affected product and stated the reason for the recall, as well as the risk to health. Customers were instructed to discontinue use of the affected device ,and complete and return the recall effectiveness check form. All affected product should be returned per the instructions provided and a credit will be issued.

Device

Device Recall VenaFlow Calf Garment (Aircast)
  • Model / Serial
    Lot 6285035.  UDI: 00885825016661.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to Texas.
  • Product Description
    3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. || Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the calf.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Address
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA