🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: July 20, 2016 Cardinal Health Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    All Lots with material number 5213PG and V5213PG
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cardinal Health
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

All Lots with material number 5213PG and V5213PG

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2917-2016

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