Device recall
Z-0309-2021: Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product…
FDA device recall · Class II · Battelle Memorial Institute
Key facts
| Recall number (Z-number) | Z-0309-2021 |
|---|---|
| Recall event | 86347 |
| Product | Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies… |
| Product code | QKY |
| Recalling firm | Battelle Memorial Institute |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 3, 2021 |
| FEI number | 1523658 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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