Device Recall Regard 의 리콜

Recall

72052

Class 2

Z-0185-2016

2015-08-25

2015-10-30

Terminated

United States

2017-04-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139787

Custom surgical kits contain a component (ors fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier. On September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the notice.