FDA Device recall Z-0364-2026
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
- FDA Device
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of ICU Medical ChemosafeLock Connecter REF: KL-FNU3 by Icu Medical, citing port weld of drug transfer device may separate or break during use and potentially result in a leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0364-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-08 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Reason
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Identifiers
| code_info | Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0364-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.