STERRAD 100NX Cassettes 의 리콜

Recall

66317

Class 2

Z-0044-2014

2013-09-18

2013-10-22

Terminated

United States

2014-01-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122040

Advanced sterilization products (asp) is recalling the three lots (13f049, 13f050, 13f051) sterrad 100nx cassettes because asp has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.

Advanced Sterilization Products (ASP) sent an Urgent Medical Device Recall letter on September 18, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to examine their inventory and return all affected cassettes using the enclosed prepaid UPS return lave to Stericycle. Customers were asked to count their inventory and record the data on the enclosed Business Reply Card and Packing Slip. Customers were asked to provide the notice to anyone in their facility that needs to be informed. Customers were also asked to maintain a copy of the notice with the affected product. Customers with questions or suspected problems were instructed to contact Stericycle directly at 1-877-257-7119. For questions regarding this recall call 949-453-6400.