Device recall
Z-0749-2018: Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-0749-2018 |
|---|---|
| Recall event | 79100 |
| Product | Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of… |
| Product code | FRG |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2018 |
| 510(k) numbers | K153540 |
| FEI number | 1527821 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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