🔍 RecallPedia

Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.

Class I - Dangerous
🏥 Medical Devices Recalled: November 16, 2018 Cardinal Health Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948
  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 Inc.
Reason for Recall:
The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.

Product Codes/Lot Numbers:

Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0702-2019

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