Device recall
Z-0356-2016: ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile…
FDA device recall · Class II · Baylis Medical Corp *
Key facts
| Recall number (Z-number) | Z-0356-2016 |
|---|---|
| Recall event | 72539 |
| Product | ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular. |
| Product code | DQX |
| Recalling firm | Baylis Medical Corp * |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2016 |
| 510(k) numbers | K014075 |
| FEI number | 3005241199 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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