FDA Device recall Z-0725-2018
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used…
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used… by Terumo Medical, citing the tucking depth feature of this catheter introducer is marginally outside the upper specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0725-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-12 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Medical |
| Distribution | n/a |
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.
Reason
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Identifiers
| code_info | Lot: VK09, Expiration Date: 31-Jan-2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0725-2018%22
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