Recall Z-3298-2024

Reason for recall

Low concentration of sodium pyruvate in the wash could compromise gamete development

FDA-determined cause: Under Investigation by firm

Action taken

CooperSurgical issued Urgent: Voluntary Medical Device Field Safety Notice on 2/16/24 via UPS Next Day Air via third party Sedgewick. Letter states reason for recall, health risk and action to take: 1) Inspect your inventory, quarantine any affected product, and immediately stop using the product. 2) Complete the appropriate version of the attached form (Customer Acknowledgement Form or Distributor Acknowledgement Form). Once completed, return the form to CooperSurgical as indicated at the top of the form. Note: Even if you do not have any affected product in your inventory ( or have not distributed any affected product to customers), please complete and return the enclosed form so that we may document receipt of this FSN. When the completed form is received by CooperSurgical, arrangements will be made for the return of any affected product at no additional cost to you. Credit will be applied to your account for product returned under this action. CooperSurgical is committed to high-quality, safe, and effective products. This corrective action has been initiated to ensure this failure mode does not reoccur and future potential patient harms can be avoided. If you have any questions, please feel free to reach us at +1 203-601-5200 ext. 3300 or recall@coopersurgical.com.