Recall Z-1887-2008 ยท HDB Extractor, Vacuum, Fetal
Cooper Surgical, Inc.
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.
| Date | Sep 17, 2008 (initiated Jan 16, 2008) |
| Status | Terminated |
| Reason | Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby. |
| Root cause | Device Design |
| Action | On 1/16/08 Cooper Surgical issued an Urgent Notice of Recall via Fed Ex for USA destinations and via e-mail and facsimile for international destinations, and firm confirmed receipt. The letter requests that accounts return recalled product. The recall was extended to three additional lots, and an Urgent Recall Notice dated 3/18/08 was issued. If you have any questions contact Thomas Williams at (203) 601-4741. |
| Distribution | Class II Recall - Worldwide Distribution --- including USA and Australia, Canada, Hong Kong, Latin America, Israel, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011532 | MITYVAC Prism Enterprises, Inc., Jul 30, 2001 |