Device recall
Z-2259-2011: Case Label: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe Qty: 20 For Rx…
FDA device recall · Class II · Nurse Assist, Inc
Key facts
| Recall number (Z-number) | Z-2259-2011 |
|---|---|
| Recall event | 58021 |
| Product | Case Label: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe 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 Tray Label: Cysto-Care Coloplast… |
| Product code | FCM |
| Recalling firm | Nurse Assist, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2012 |
| FEI number | 3002695476 |
At a glance
- None 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