Device Recall Zero 의 리콜

Recall

64246

Class 2

Z-0838-2013

2013-01-14

2013-02-20

Terminated

United States

2015-08-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115660

Out of an abundance of caution, ansell is implementing a voluntary recall of the zero latex condom (regular) product. the condom has met or exceeded test and quality standards required by the food and drug administration. however, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.

Ansell HealthCare Product LLC sent an Recall letter dated January 14, 2013, via registered mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recall notification informs customers about the problem with the affected product and provides instructions to the customers on how to handle affected product. Customers are asked to complete the Response Form and return via fax (1-800) 722-8155. If you have further questions, please contact our Customer Service Department at 1-800-952-9916.