🔍 RecallPedia

Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing

Class I - Dangerous
🏥 Medical Devices Recalled: May 14, 2012 Hartmann USA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Item # 416105 (Econolux): 101546391, 101646398, 101747392, 101850399, 101952309, 200106397
  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:
Hartmann USA, Inc
Reason for Recall:
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing

Product Codes/Lot Numbers:

Item # 416105 (Econolux): 101546391, 101646398, 101747392, 101850399, 101952309, 200106397

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1857-2012

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