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Terminated

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.

FDA Recall Z-2989-2011 · Posted 2011-08-10

Recalling FirmCarl Zeiss Meditec, Inc.
Recall StatusTerminated
Product CodeJAD
Date Initiated2011-07-01
Date Terminated2011-10-13
Product Quantity8 boxes of 10 sterile packages.

Reason for Recall

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,

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090584INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETSCarl Zeiss Surgical GmbH · 2009-11-24K051055INTRABEAM SYSTEMCarl Zeiss Surgical GmbH · 2005-05-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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