🔍 RecallPedia

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;

Class I - Dangerous
🏥 Medical Devices Recalled: February 4, 2020 Deroyal Industries, Inc. Lafollette Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Outpatient Major 89-3865.12, Lot numbers: 47061206 exp. 06/01/2022, 49505579 exp. 03/01/2023, 4955103 exp. 03/01/2023
  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:
Deroyal Industries, Inc. Lafollette
Reason for Recall:
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;

Product Codes/Lot Numbers:

Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Outpatient Major 89-3865.12, Lot numbers: 47061206 exp. 06/01/2022, 49505579 exp. 03/01/2023, 4955103 exp. 03/01/2023

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1410-2020

Related Recalls