Device recall
Z-0838-2013: LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell…
FDA device recall · Class II · Ansell Healthcare Products LLC
Key facts
| Recall number (Z-number) | Z-0838-2013 |
|---|---|
| Recall event | 64246 |
| Product | LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually… |
| Product code | HIS |
| Recalling firm | Ansell Healthcare Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 6, 2015 |
| 510(k) numbers | K120394 |
| FEI number | 3009964047 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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