Device recall
Z-1094-2019: icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated…
FDA device recall · Class I · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1094-2019 |
|---|---|
| Recall event | 82291 |
| Product | icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6… |
| Product code | FPA |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 4, 2024 |
| FEI number | 2025816 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database