🔍 RecallPedia

Reduction Mammoplasty Pack, part number AMS4380 Reduction Mammoplasty Pack, part number AMS4380(B

Class I - Dangerous
🏥 Medical Devices Recalled: January 11, 2017 Windstone Medical Packaging Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot number and expiration date 84592, 11/18/2017 85070, 11/8/2017 86795, 2/27/2018 89930, 9/1/2018 99074, 11/27/2018
  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:
Windstone Medical Packaging, Inc.
Reason for Recall:
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Reduction Mammoplasty Pack, part number AMS4380 Reduction Mammoplasty Pack, part number AMS4380(B

Product Codes/Lot Numbers:

Lot number and expiration date 84592, 11/18/2017 85070, 11/8/2017 86795, 2/27/2018 89930, 9/1/2018 99074, 11/27/2018

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1364-2017

Related Recalls