Device recall
Z-1584-2009: Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6…
FDA device recall · Class II · Ansell Healthcare Products LLC
Key facts
| Recall number (Z-number) | Z-1584-2009 |
|---|---|
| Recall event | 52038 |
| Product | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room… |
| Product code | KGO |
| Recalling firm | Ansell Healthcare Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2010 |
| 510(k) numbers | K984558 |
| FEI number | 1019632 |
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