Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
This recall has been terminated (originally issued May 4, 2017).
- Company
- Terumo Medical Corporation
- Recall Initiated
- November 6, 2015
- Posted
- May 4, 2017
- Terminated
- May 12, 2017
- Recall Number
- Z-2033-2017
- Quantity
- 5,252 eaches
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
Root Cause
Other
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.