Device recall
Z-1123-2018: 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage…
FDA device recall · Class II · Medical Components, Inc dba MedComp
Key facts
| Recall number (Z-number) | Z-1123-2018 |
|---|---|
| Recall event | 79436 |
| Product | 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. |
| Product code | NFK |
| Recalling firm | Medical Components, Inc dba MedComp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2020 |
| 510(k) numbers | K022570 |
| FEI number | 2518902 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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