🔍 RecallPedia

ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

Class I - Dangerous
🏥 Medical Devices Recalled: February 19, 2015 Arc Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Product code: 6160, Batch number: 110208-50
  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:
Arc Medical Inc
Reason for Recall:
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

Product Codes/Lot Numbers:

Product code: 6160, Batch number: 110208-50

Distribution:

Distributed in: CA, NC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1596-2015