Device recall
Z-2054-2017: CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and…
FDA device recall · Class II · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-2054-2017 |
|---|---|
| Recall event | 76980 |
| Product | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with… |
| Product code | HHW |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2017 |
| 510(k) numbers | K904026, K904774 |
| FEI number | 1216677 |
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