INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
- Company
- Carl Zeiss Meditec Inc
- Recall Initiated
- October 25, 2012
- Posted
- November 20, 2012
- Terminated
- November 20, 2012
- Recall Number
- Z-0404-2013
- Quantity
- 36 tootal, all lots
- Firm Location
- Dublin, CA
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
Nationwide Distribution including IL and MD
Lot / Code Info
Part number 304534-7500-000; lot number 540958.
Root Cause
Nonconforming Material/Component
Action Taken
Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc. A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product. For questions customers were instructed to call 925-580-5371 or by email at v.venturo@meditec.zeiss.com. For questions regarding this recall call 925-557-4616.