Curlin Ambulatory Infusion Administration Set 의 리콜

Recall

63359

Class 2

Z-0072-2013

2012-10-17

Terminated

United States

2013-04-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113568

This recall is the same issue for the fda processed recall initiated by moog medical devices on 1/25/11 which was related to customers reporting unclearable air-in-line alarm with specific lot numbers of curlin administration sets used with curlin ambulatory infusion pumps. the lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by.

MOOG sent a Medical Device Recall Notification letter dated September 26, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove product from their inventory and return to the firm. Customers were also instructed to contact their distributor to arrange for replacement product. For questions customers were instructed to call 1-800-970-2337, prompt #7. For questions regarding this recall call 801-264-1001.