Device Recall SmartSite Low Sorbing Infusion Set 의 리콜

Recall

66150

Class 2

Z-2279-2013

2013-08-30

2013-09-26

Terminated

United States

2013-10-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121570

Carefusion is recalling the smartsite low sorbing infusion set, model 72313e, lot number 13016314, because of an incorrect filter was assembled on this lot. the correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.

CareFusion sent an Urgent Medical Device Recall Notification dated August 30, 2013, to all affected customers. The letter informed the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers were instructed to immediately check their inventory for the affected product, if any affected product is encountered, customers were instructed not to use. Customers were instructed to complete the customer response form and return the form to CareFusion with the affected product for replacement.. A distributor letter was also sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors were instructed to contact the Customer Support Team, return customer response form, and if they have questions then they were instructed to contact the CareFusion Support Center at 1-800-562-6018. For questions regarding this recall call 858-617-4000.