IVEA 500A Intended for Med-Surg patient care.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
- 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:
- Firefly Medical, Inc.
- Reason for Recall:
- The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
IVEA 500A Intended for Med-Surg patient care.
Product Codes/Lot Numbers:
Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0767-2017
Related Recalls
IVEA Product Part Number 16100 Model 500A
Firefly Medical
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.