🔍 RecallPedia

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

Class I - Dangerous
🏥 Medical Devices Recalled: January 5, 2015 Terumo Cardiovascular Systems Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Catalog Number: 401-231, Product Description: Titan" Stabilizer Attachment , Lot Number: 052R Catalog Number 401-231u , Product Description TitanTM 360 Stabilizer Attachment , Lot Number: 020R, 024R, 026R, 029R, 030R,034R,035R,037R, 040 , 048R
  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:
Terumo Cardiovascular Systems Corporation
Reason for Recall:
Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. Although the clip is for convenience purposes and is not required for device operation, there is a potential for broken Suction Tubing Clip fragments to fall into the surgical site.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

Product Codes/Lot Numbers:

Catalog Number: 401-231, Product Description: Titan" Stabilizer Attachment , Lot Number: 052R Catalog Number 401-231u , Product Description TitanTM 360 Stabilizer Attachment , Lot Number: 020R, 024R, 026R, 029R, 030R,034R,035R,037R, 040 , 048R

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1232-2017

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