Device Recall Esmark Elastic Bandage 의 리콜

Recall

67858

Class 2

Z-1649-2014

2014-03-20

2014-05-21

Terminated

United States

2017-11-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126504

This lot did not go through the correct sterilization procedures. this product may potentially be non-sterile.

Medline Industries issued an Immediate Action Required letter dated March 20, 2014 to all affected customers. The letters included instructions to: 1) immediately check inventories for the recalled products and quarantine the recalled products; 2) complete and return the enclosed destruction form listing the quantity of destroyed product (credit will only be issued if the completed form is received); and 3) If the customer is a distributor, promptly notify the distributor's customers that may have received the recalled products about this recall. Direct accounts and their customers that have any questions can contact Medline Industries at 866-359-1704.