INTRABEAM Shielding Material Flat 20 x 20 cm…

Date posted by the FDA

Aug. 10, 2011

Status

Terminated

Filed by

Carl Zeiss Meditec, Inc.

Product

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.

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,

Distribution pattern

Nationwide (USA) Distribution including the states of FL, CA, NY, VA and AL.

Quantity

8 boxes of 10 sterile packages.

Codes and lots

Lot 110851; Catalog number 304534-6000-585.

Recall started

July 1, 2011

Device type

System, Therapeutic, X-Ray

Root cause (FDA)

Process control

What the company told customers

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.

Recall number

Z-2989-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2989-2011. The agency record governs; check it and the company before acting.