INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part number 304534-7500-000; lot number 540958.
- 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:
- Carl Zeiss Meditec, Inc.
- Reason for Recall:
- A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
Product Codes/Lot Numbers:
Part number 304534-7500-000; lot number 540958.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0404-2013
Related Recalls
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Carl Zeiss Meditec
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Carl Zeiss Meditec
Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch.