INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated f

FDA device recall Z-2989-2011 · posted 2011-08-10 · Terminated

Recall details

Recalling firm

Carl Zeiss Meditec, Inc.

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,

Action taken

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

Status

Terminated

Product code

JAD

Quantity affected

8 boxes of 10 sterile packages.

Distribution

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

Date initiated

2011-07-01

Date posted

2011-08-10

Date terminated

2011-10-13

Location

Dublin, CA

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