Device recall
Z-1681-2022: Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG…
FDA device recall · Class II · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1681-2022 |
|---|---|
| Recall event | 90606 |
| Product | Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike w ChemoLock Port/CL2150… |
| Product code | ONB |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K131549 |
| FEI number | 2025816 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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