🔍 RecallPedia

Major Laparotomy Pack - NS, part number AMS4347

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 78636, 4/16/2017 98273, 6/10/2019
  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:

Major Laparotomy Pack - NS, part number AMS4347

Product Codes/Lot Numbers:

Lot number and expiration date 78636, 4/16/2017 98273, 6/10/2019

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1339-2017

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