Recall Z-0098-2019

Reason for recall

The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

FDA-determined cause: Other

Action taken

Urgent Medical Device Recall Notification letters dated 9/4/18 were distributed to customers. The letters instruct customers do the following: Please be advised that CooperSurgical has initiated a corrective action to inspect finished goods in inventory for potential unsealed pouches. If any product from the 26 lots is in your possession and has a green label affixed to the outer display box as displayed below, it is not affected by this recall action. A product is acceptable for use if it is visually confirmed that the pouchs seal is intact. As indicated in the Directions for Use (DFU), each package should be handled with care and inspected for damage, including the seal area before use. Inspect the package contents and the sterile seal along the entire periphery of the package. Refer to the table below for examples of acceptable / not acceptable conditions. Please discontinue use of the product with any packaging irregularities, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Once the form is completed and returned to CooperSurgical, a Customer Service Representative will contact you with a Return Merchandise Authorization (RMA) number and provide instructions for the return of product to CooperSurgical. If replacements are requested, a replacement order will be placed immediately. If you do not have affected stock, please complete and return the enclosed Acknowledgement and Receipt Form, in order for us to document receipt of this letter.