INTRABEAM Balloon Applicator Set 의 리콜

Recall

63596

Class 2

Z-0404-2013

2012-10-25

2012-11-20

Terminated

United States

2012-11-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114295

A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.

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.