Device recall
Z-1531-2017: ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-1531-2017 |
|---|---|
| Recall event | 76201 |
| Product | ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus… |
| Product code | JWY |
| Recalling firm | BioMerieux SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2020 |
| 510(k) numbers | K102668 |
| FEI number | 1000611339 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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