Device recall
Z-1529-2017: ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-1529-2017 |
|---|---|
| Recall event | 76201 |
| Product | ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. 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 species and… |
| Product code | JWY |
| Recalling firm | BioMerieux SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2020 |
| 510(k) numbers | K960989 |
| 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