FDA Device recall Z-2337-2018
Angio-Seal Evolution Vascular Closure Device, Cat
- FDA Device
- Class II
- terminated
- Published 2018-07-11
On 2018-07-11 the FDA classified a Class II recall of Angio-Seal Evolution Vascular Closure Device, Cat by Terumo Medical, citing two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2337-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-09 |
| Published | 2018-07-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Medical |
| Distribution | AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, TX |
Product
Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Reason
Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
Identifiers
| code_info | 5980075, 5980077 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
FDA Device · Class II · 2019-07-31 · Terumo Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2337-2018%22
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