Recall Z-2989-2011 ยท JAD System, Therapeutic, X-Ray
Carl Zeiss Meditec, Inc.
INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments.
| Date | Aug 10, 2011 (initiated Jul 1, 2011) |
| Status | Terminated |
| Reason | Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol, |
| Root cause | Process control |
| Action | Carl Zeiss Meditec, Inc. sent an "Important Field Correction Action" letter dated July 13, 2011 to all affected customers. The letter included description of affected product and problem. Customers are asked to notify the firm if they have experienced any problems with the product and to return any remaining product for replacement upon completion of required testing. Customers are asked to fill out and return an Acknowledgement Form. For additional information contact Carl Zeiss Meditec at (925) 570-4844. |
| Quantity | 8 boxes of 10 sterile packages. |
| Distribution | Nationwide (USA) Distribution including the states of FL, CA, NY, VA and AL. |
| FDA record | Open on fda.gov |