Device Recall Destination Renal Guiding Sheath Catheter introducer/Guiding Sheath 의 리콜

Recall

76939

Class 2

Z-2033-2017

2015-11-06

2017-05-04

Terminated

United States

2017-05-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154646

Based on internal investigation and testing that revealed the distal end of certain lots of terumo medical destination¿ products may not contain the labeled 5 cm of coating. while there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.

An Urgent Product Bulletin Recall of Terumo Medical Product letter, dated November 6, 2015, was sent to customers. The letter identified the affected product and the reason for the voluntary recall. The letter asked customers to immediately discontinue use and quarantine any of the affected product listed. Customers are to complete the enclosed Contact & Inventory Confirmation Form and e-mail DSRenalRecall@terumomedical.com or fax to 732-412-4121, Attn: Destination Recall. For questions or further information, customers can contact Customer Care at 800-888-3786 or their local sales representative.