Events

Recall of Device Recall Cardinal Health BLUE IMPERVIOUS GOWN WITH THUMBHOOKS

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

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
    75019
  • Event Risk Class
    Class 2
  • Event Number
    Z-2917-2016
  • Event Initiated Date
    2016-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149126
  • 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
    Non-surgical isolation gown - Product Code OEA
  • Reason
    Blue impervious gown with thumbhooks, x-large. all lots do not meet design specifications, specifically 16 cfr 1611 - standard for the flammability of vinyl plastic film. the standard defines a specific test method that quantifies the rate of flame propagation against a minimum value using an engineered test fixture. the method requires that the test be performed on different orientations of the film (machine direction and cross direction). the machine direction is defined by the manufacturing process generating the film. the formed film exits the machine moving in the machine direction. the cross direction is at 90 degrees to the machine direction. the more rapid burning direction defines the results of the test (either a pass or fail). the products being recalled failed when tested in the machine direction with a result of 1.9-2.0 inches/second versus a limit of 1.2 inches/second. they passed by self-extinguishing when tested in the cross direction.
  • Action
    The firm sent an URGENT: PRODUCT RECALL dated 7/20/2016 describing the reason for the recall. The letter also provides instructions for the user on how to address this issue. Cardinal Health anticipates replacement inventory of 5213PG will be available by August 22, 2016 and V5213PG by August 29. Until that time, the recommended substitute product is 5210PG, which shares all the design characteristics of 5213PG (blue polyethylene film material, over-the-head donning/tear-away removal, half-back, thumb hook wrists) and comes in similar packaging (15 individually packed gowns per box, 5 boxes per case for a total of 75 gowns per case). The firm advises that the 5210PG is "Universal" size, which is smaller than 5213PG (XL size), so it may not work for all users. The firm is requesting all customers to take the following actions: 1. Immediately stop distributing affected product. 2. Return the enclosed acknowledgment form via fax to 847.689.9101, whether or not they have affected product, as Cardinal Health is required to confirm receipt of this notification. 3. Contact the Distributor Management Customer Service team at 800.635.6021 to arrange for credit and return of any affected product they may have. 4. Customers do not need to notify any customers to whom they may have distributed product affected by this recall. If they have any questions relating to this recall, please contact Cardinal Health Customer Advocacy at 800.292.9332.

Device

Device Recall Cardinal Health BLUE IMPERVIOUS GOWN WITH THUMBHOOKS
  • Model / Serial
    All Lots with material number 5213PG and V5213PG
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide to U.S. consignees located in the following states:AL ,AR ,AZ ,CA ,CT ,FL ,GA ,IL ,IN ,KY ,LA ,MA ,MD ,MI ,MO ,NC ,NJ ,NM ,NV ,NY ,OH ,PA ,SC ,TX ,UT ,VA ,WA and WV.
  • Product Description
    BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific. || An isolation gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1430 S Waukegan Rd, Waukegan IL 60085-6726
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA