Device Recall ENCORE(R) UNDERGLOVE 의 리콜

Recall

59155

Class 2

Z-2840-2011

2011-06-10

2011-07-18

Terminated

United States

2013-01-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101413

Gloves do not meet the tensile requirements of astm d 3577 reducing the shelf life of the product from 5 years to 2 years.

Ansell Healthcare Products LLC sent an Urgent Voluntary Recall letter dated June 9, 2011, to all affected customers on June 10 and 13, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue use and distribution of any of the affected product and return them to the firm. If the customer distributed gloves further, customers were advised to forward a copy of the notification letter along with their tracking number to their customers. Customers were instructed to complete and return the attached Response Form to Ansell by fax at 1-800-722-8155. Returned product would be replaced or credited to the customer.