Recall Z-0005-05 ยท HDB Extractor, Vacuum, Fetal
CooperSurgical, Inc.
Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047
| Date | Oct 5, 2004 (initiated Aug 17, 2004) |
| Status | Terminated |
| Reason | Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System |
| Root cause | Other |
| Action | CooperSurgical telephoned consignees on 8/18/04 and sales representatives to visit the account for removal of recalled product. |
| Quantity | 495 units |
| Distribution | FL, IA, KS, GA, MA, MN, MS, NE, NY, OH, OK, VA, ME, TX, VA Foreign: Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011532 | MITYVAC Prism Enterprises, Inc., Jul 30, 2001 |