Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#'s: M551490 and M550150
- 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:
- Civco Medical Instruments Inc
- Reason for Recall:
- Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Product Codes/Lot Numbers:
Lot#'s: M551490 and M550150
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0803-2014
Related Recalls
Leaks were detected in the recalled lot which may compromise the sterility of the product.
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.