Class 2 Device Recall VASOVIEW HEMOPRO

• Date Initiated by Firm: March 06, 2023
• Date Posted: April 04, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1337-2023
• Recall Event ID: 91764
• 510(K)Number: K153194
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
• Code Information: UDI-DI: 00607567700345; Lot Numbers: 3000274687
• Recalling Firm/ Manufacturer: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Stephanie Moretti; 973-709-7170
• Manufacturer Reason for Recall: Some batches of product were not sterilized to their minimum sterilization specification.
• FDA Determined Cause: Process control
• Action: An Urgent Medical Device Removal notification letter dated 3/3/23 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received the Hemopro lot(s) affected by this recall. Please, note that Distributed Affected Lot Number(s) appear on the device shelf boxes only. Please examine your inventory immediately to determine if you have any of the Hemopro with the product code/lot number(s) listed in this notice. " Should you have any affected product lot(s) as listed in this notification, please stop using and remove the complete device from areas of use. If you have affected product, you are entitled to a credit. You will receive credit upon your acknowledgement that you have affected product for return. " Please forward this information to all current and potential Hemopro and Hemopro 2 users within your hospital / facility. " If you are a distributor who has shipped any affected product(s) to customers, please forward this document to their attention for appropriate action. " Please contact Getinge Customer Service at 888-880-2874 between the hours of 6:00 a.m. and 5:00 p.m. Pacific Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. " Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet Cardiovascular, LLC /Getinge by e-mailing a scanned copy to Hemopro2023Sterility.act@getinge.com or by faxing the form to 1-800-385-0294 . We apologize for any inconvenience this recall may cause. If you have any questions, please contact your Maquet Cardiovascular, LLC /Getinge representative or call the Getinge Customer Service at (888)
• Quantity in Commerce: 235 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Brazil, China.
• 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 = GEI and Original Applicant = MAQUET CARDIOVASCULAR, LLC