BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
- 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:
- Avanos Medical, Inc.
- Reason for Recall:
- Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Product Codes/Lot Numbers:
All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1189-2023
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