Device recall
Z-0918-2020: Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a)…
FDA device recall · Class II · ROi CPS LLC
Key facts
| Recall number (Z-number) | Z-0918-2020 |
|---|---|
| Recall event | 84643 |
| Product | Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line… |
| Product code | LRO |
| Recalling firm | ROi CPS LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2020 |
| FEI number | 3014527682 |
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