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U.S. Department of Health and Human Services

Class 2 Device Recall INTRABEAM Balloon Applicator Set

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 Class 2 Recall
INTRABEAM Balloon Applicator Set
see related information
Date Posted November 20, 2012
Recall Status1 Terminated on November 20, 2012
Recall Number Z-0405-2013
Recall Event ID 63596
Premarket Notification
510(K) Number
K090584 
Product Classification System, Therapeutic, X-Ray - Product Code JAD
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
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAD and Original Applicant = CARL ZEISS SURGICAL GMBH
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