FDA Device recall Z-0365-2026
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
- FDA Device
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3 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-0365-2026 |
| 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 Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Reason
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Identifiers
| code_info | Lot:KL-VA001U3: 14360690 14345871 14367719 14381368 14381367; KL-VA002U3: 14345872; KL-VA131U3: 14381373; KL-VA201U3: 1…Lot:KL-VA001U3: 14360690 14345871 14367719 14381368 14381367; KL-VA002U3: 14345872; KL-VA131U3: 14381373; KL-VA201U3: 14337455 14381355 14381358; KL-VA202U3: 14367718, KL-VA321U3: 14345878 ; 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-0365-2026%22
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