Recall Z-0404-2013— Carl Zeiss Meditec, Inc.

Name: FDA recall Z-0404-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-25

Class II · Terminated

Class II FDA medical device recall by Carl Zeiss Meditec, Inc., initiated 2012-10-25, terminated 2012-11-20. It names one FDA 510(k) clearance: K090584. Product: INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments. Reason: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve..

Recalling firm: Carl Zeiss Meditec, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Terminated: 2012-11-20
Firm location: Dublin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K090584 — INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETSCarl Zeiss Surgical GmbH·cleared 2009-11-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.