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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
INTRABEAM Balloon Applicator Set		see related information
Date Posted November 20, 2012
Recall Number Z-0405-2013
Product INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Code Information Part number 304534-7500-001; lot number 540959.
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec, Inc.
5160 Hacienda Dr
Dublin, California 94568-7562
For Additional Information Contact Judith A. Brimacombe, M.A
925-557-4616
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.
Action 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.
Quantity in Commerce 36 total, all lots
Distribution Nationwide Distribution including IL and MD
 
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