Device recall
Z-1182-2018: First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for…
FDA device recall · Class II · Madison Polymeric Engineering
Key facts
| Recall number (Z-number) | Z-1182-2018 |
|---|---|
| Recall event | 79402 |
| Product | First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to… |
| Product code | MNL |
| Recalling firm | Madison Polymeric Engineering |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2018 |
| FEI number | 3001451466 |
At a glance
- None Linked 510(k)s
- 1–9 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