Device recall
Z-0828-2024: Custom procedural convenience kits and trays, Obstetrical & Gynecological use…
FDA device recall · Class II · American Contract Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0828-2024 |
|---|---|
| Recall event | 93656 |
| Product | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit… |
| Product code | OHD |
| Recalling firm | American Contract Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3003309947 |
At a glance
- None Linked 510(k)s
- 10–99 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