Carl Zeiss Meditec, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0405-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.

Product Classification:

Class II

Date Initiated: October 25, 2012

Date Posted: November 28, 2012

Recall Number: Z-0405-2013

Event ID: 63596

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.

Status: Terminated

Product Quantity: 36 total, all lots

Code Information:

Part number 304534-7500-001; lot number 540959.

Distribution Pattern:

Nationwide Distribution including IL and MD

Voluntary or Mandated:

Voluntary: Firm initiated