Z-0405-2013 Class II Terminated
FDA device recall Z-0405-2013 was initiated by Carl Zeiss Meditec, Inc. on October 25, 2012 and is designated Class II. 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. The recall status is terminated (terminated November 20, 2012). Affected quantity: 36 total, all lots.
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- October 25, 2012
- Termination Date
- November 20, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 total, all lots
Product Description
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
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.
Distribution Pattern
Nationwide Distribution including IL and MD
Code Information
Part number 304534-7500-001; lot number 540959.