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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Recall Notice. CooperSurgical contact:: 203-601-5200 ext. 3300.