Device recall
Z-0504-2012: REF UT8140 Urethal Insertion Tray Qty: 20 For Rx Only Sterile unless package is…
FDA device recall · Class II · Nurse Assist, Inc
Key facts
| Recall number (Z-number) | Z-0504-2012 |
|---|---|
| Recall event | 60412 |
| Product | REF UT8140 Urethal Insertion Tray Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway… |
| Product code | KOD |
| Recalling firm | Nurse Assist, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2012 |
| 510(k) numbers | K830359 |
| FEI number | 3002695476 |
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