FDA Device recall Z-0116-2016
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960
- FDA Device
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960 by Concentric Medical, citing one Distal Access Catheter intended for distribution in Korea, was found at a US location.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0116-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-19 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Concentric Medical |
| Distribution | KY |
Product
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
Reason
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Identifiers
| code_info | Lot no. 37603 Expiration date: September 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0116-2016%22
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