MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 9448532 9448838 9448979 9449000 9449237
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- MY01, INC.
- Reason for Recall:
- There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Product Codes/Lot Numbers:
Lot Numbers: 9448532 9448838 9448979 9449000 9449237
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2384-2021