Device product
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.
Z-0725-2018
Product summary
- Event
- Event 79167
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33
- Official record key
device-enforcement:Z-0725-2018
Official wording
Reason: The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Code information: Lot: VK09, Expiration Date: 31-Jan-2020
Distribution pattern: To be added.
Derived failure modes
-
Unknown
The tucking depth feature of this catheter introducer is marginally outside the upper specification.