Device recall
Z-0169-2016: Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting…
FDA device recall · Class II · Welch Allyn Inc
Key facts
| Recall number (Z-number) | Z-0169-2016 |
|---|---|
| Recall event | 72228 |
| Product | Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY |
| Product code | HIB |
| Recalling firm | Welch Allyn Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2018 |
| 510(k) numbers | K120743 |
| FEI number | 1316463 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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