Recall Z-2498-2020 ยท LOB Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
CooperSurgical, Inc.
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
| Date | Jun 3, 2020 |
| Status | Terminated |
| Reason | Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the correct Os FinderTM Cervical Dilators, Part Number 1176. The product in the individual product package is the correct Os Finder Cervical Dilator |
| Root cause | Labeling design |
| Action | Cooper Surgical issued letter dated 6/3/20/20 via Certified Mail stating reason for recall, health risk and action to take: Please discontinue use of and quarantine Products with any packaging irregularities, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected Products are returned to CooperSurgical. If you |
| Quantity | 2,250 units (45 boxes of 50) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.