Device recall
Z-0091-2019: Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male…
FDA device recall · Class II · Reckitt Benckiser LLC
Key facts
| Recall number (Z-number) | Z-0091-2019 |
|---|---|
| Recall event | 80939 |
| Product | Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease). |
| Product code | MOL |
| Recalling firm | Reckitt Benckiser LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 12, 2019 |
| 510(k) numbers | K072169 |
| FEI number | 3011015568 |
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