INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
FDA Recall Z-0405-2013 · Posted 2012-11-20
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Recalling FirmCarl Zeiss Meditec, Inc.
Recall StatusTerminated
Product CodeJAD
Date Initiated2012-10-25
Date Terminated2012-11-20
Product Quantity36 total, all lots
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.
Firm 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 [email protected].
For questions regarding this recall call 925-557-4616.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including IL and MD
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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