Device recall
Z-1824-2015: McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose…
FDA device recall · Class II · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-1824-2015 |
|---|---|
| Recall event | 71313 |
| Product | McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures |
| Product code | HIB |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2016 |
| 510(k) numbers | K841909 |
| FEI number | 1216677 |
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