Recall Z-0725-2018 ยท DYB Introducer, Catheter
Terumo Medical Corporation
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.
| Date | Sep 12, 2017 |
| Status | Terminated |
| Reason | The tucking depth feature of this catheter introducer is marginally outside the upper specification. |
| Root cause | Process control |
| Action | Terumo sent an Urgent Medical Device Recall dated September 12, 2017 to affected customers. The letter identified the affected product problem and actions to be taken. The informed customers that a territory managers will visit each institution to examine the inventory, identify the affected product and lot, and prepare the product for return to Terumo Medical Corporation. There is an inventory confirmation form that is returned by the sales representative to the recalling site. |
| Quantity | 33 |
| Distribution | To be added. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012584 | MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT Bd, Sep 6, 2001 |