Device recall
Z-1908-2021: Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover…
FDA device recall · Class II · Exact Medical Manufacturing, Inc.
Key facts
| Recall number (Z-number) | Z-1908-2021 |
|---|---|
| Recall event | 87958 |
| Product | Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA |
| Product code | ITX |
| Recalling firm | Exact Medical Manufacturing, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 26, 2022 |
| FEI number | 3008011779 |
At a glance
- None 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