🔍 RecallPedia

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Class I - Dangerous
🏥 Medical Devices Recalled: November 2, 2021 Cardinal Health Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)
  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:
Potential for open packaging seals compromising the sterility of the surgical gowns
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Product Codes/Lot Numbers:

Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0375-2022

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