Device recall
Z-0920-2012: The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric…
FDA device recall · Class II · Novomedicus Llc
Key facts
| Recall number (Z-number) | Z-0920-2012 |
|---|---|
| Recall event | 60844 |
| Product | The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only. Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. 2. 60cm x 85 cm Steri Drape 3. Drain with Connector 4. 4 x Gauze Rolls Sterile… |
| Product code | FTL |
| Recalling firm | Novomedicus Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2012 |
| 510(k) numbers | K093166 |
| FEI number | 3008519417 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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