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.
This recall has been terminated (originally issued September 12, 2017).
- Company
- Terumo Medical Corporation
- Recall Initiated
- September 12, 2017
- Terminated
- August 31, 2018
- Recall Number
- Z-0725-2018
- Quantity
- 33
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Distribution
To be added.
Lot / Code Info
Lot: VK09, Expiration Date: 31-Jan-2020
Root Cause
Process control
Action Taken
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.