Device recall
Z-2297-2023: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound…
FDA device recall · Class II · MEDLINE INDUSTRIES, LP - Northfield
Key facts
| Recall number (Z-number) | Z-2297-2023 |
|---|---|
| Recall event | 92399 |
| Product | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A; d… |
| Product code | OES |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1417592 |
At a glance
- None 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