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FDA device recall Z-2033-2017 · posted 2017-05-04 · Terminated

Recall details

Recalling firm

Terumo Medical Corporation

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

DYB

Quantity affected

5,252 eaches

Distribution

Nationwide Distribution.

Date initiated

2015-11-06

Date posted

2017-05-04

Date terminated

2017-05-12

Location

Elkton, MD

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