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SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue

Class I - Dangerous
🏥 Medical Devices Recalled: June 2, 2014 Smith & Nephew, Inc. Endoscopy Division Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684
  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:
Smith & Nephew, Inc. Endoscopy Division
Reason for Recall:
Sterility of device is compromised due to breach in sterile barrier
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue

Product Codes/Lot Numbers:

Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2049-2014

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