FDA Device recall Z-0334-2026
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"
- FDA Device
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros" 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-0334-2026 |
| 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 Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
Reason
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Identifiers
| code_info | UDI:10887709076768/Lot: 14400216, 14416769 |
|---|
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-0334-2026%22
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