Device recall
Z-1887-2008: M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref…
FDA device recall · Class II · Cooper Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1887-2008 |
|---|---|
| Recall event | 46377 |
| Product | M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections. |
| Product code | HDB |
| Recalling firm | Cooper Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2012 |
| 510(k) numbers | K011532 |
| 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