🔍 RecallPedia

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

Class I - Dangerous
🏥 Medical Devices Recalled: September 4, 2018 CooperSurgical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871
  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:
CooperSurgical, Inc.
Reason for Recall:
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

Product Codes/Lot Numbers:

Lots 244660, 245964, 250426, 251395 , 244667, 244883, 244884, 245603, 245973, 246138, & 248871

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3278-2018

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