Anterior Hip Pack - Surgical Kit

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    SKU/Part Number 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943
  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:
Stradis Medical, LLC dba Stradis Healthcare
Reason for Recall:
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Anterior Hip Pack - Surgical Kit

Product Codes/Lot Numbers:

SKU/Part Number 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0865-2022

Related Recalls

Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Other Medical Devices Nationwide View Details →
Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Other Medical Devices Nationwide View Details →