Recall Z-2033-2017 ยท DYB Introducer, Catheter
Terumo Medical Corporation
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
| Date | May 4, 2017 (initiated Nov 6, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 repres |
| Quantity | 5,252 eaches |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012854 | RENAL GUIDING SHEATH Terumo Medical Corp., Nov 21, 2001 |