Device recall
Z-0636-2022: KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK"…
FDA device recall · Class III · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-0636-2022 |
|---|---|
| Recall event | 89412 |
| Product | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse… |
| Product code | JTR |
| Recalling firm | Microbiologics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 22, 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