🔍 RecallPedia

The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

Class I - Dangerous
🏥 Medical Devices Recalled: October 24, 2014 Aesculap Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Item Number FV129 Lot Number 4506244166 Serial Number A10150
  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:
Aesculap, Inc.
Reason for Recall:
Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

Product Codes/Lot Numbers:

Item Number FV129 Lot Number 4506244166 Serial Number A10150

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0502-2015

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