Device recall
Z-0304-2021: Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of…
FDA device recall · Class II · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-0304-2021 |
|---|---|
| Recall event | 86576 |
| Product | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the… |
| Product code | JTR |
| Recalling firm | Microbiologics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2022 |
| 510(k) numbers | K861022 |
| FEI number | 2150138 |
At a glance
- 1–9 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