Class 2 Device Recall Global Total LP

• Date Initiated by Firm: February 13, 2023
• Date Posted: April 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1348-2023
• Recall Event ID: 91794
• 510(K)Number: K142991
• Product Classification: Media, reproductive - Product Code MQL
• Product: Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
• Code Information: UDI-DI: 00815965020433; LOT 221118-010694
• FEI Number: 1216677
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 95 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: 203-601-5200
• Manufacturer Reason for Recall: It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.
• FDA Determined Cause: Labeling Change Control
• Action: An URGENT: VOLUNTARY MEDIA RECALL dated 1/26/23 was sent to customers. Actions to be Taken: For both CUSTOMERS and DISTRIBUTORS: " Inspect your stock for the Product from this lot. Lot information can be found on the box and bottle labeling. o If found, quarantine, and discontinue use of the Product from this lot immediately. o Please complete and return the appropriate enclosed Acknowledgment Form (even if you do not have the specific lot remaining in stock) to initiate our recall return process. Credit will be applied to your account to reorder replacement product, as per our recall process, with no additional cost to you or your facilities. o The form can be returned to CooperSurgical via email at Recall@coopersurgical.com or via fax at +1.203.601.9870 Please feel free to contact your local account manager or contact us at +1-203-601-5200 Monday Friday 09:00 17:00 EST, and follow the phone prompt to enter the ext. 3300 or via email at Recall@coopersurgical.com. If affected Product has been distributed to customers, please select one of the following options: " I have identified and notified all customers to whom the affected Product may have been distributed. " I am providing a list of all customers to whom affected Product may have been distributed along with their contact information.
• Quantity in Commerce: 190 units
• Distribution: Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MQL