Class 2 Device Recall Maquet Bubble Sensor

• Date Initiated by Firm: December 28, 2023
• Date Posted: February 08, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1053-2024
• Recall Event ID: 93772
• 510(K)Number: K133598
• Product Classification: Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
• Product: Bubble Sensor (REF: 70105.5720)
• Code Information: Model: BS 3/8x3/32 L1.7; Correct UDI DI: 04037691816432; Incorrect UDI DI (as labeled): 04058863025148; SNs: 90041799 90041816 90041938 90042009 90042069 90041802 90041817 90041939 90042011 90042070 90041804 90041818 90041940 90042036 90042071 90041805 90041821 90041943 90042037 90042074 90041806 90041822 90041957 90042038 90042076 90041807 90041823 90041963 90042042 90042079 90041808 90041826 90041966 90042049 90042083 90041809 90041836 90041974 90042050 90042085 90041810 90041898 90041983 90042054 90042089 90041811 90041905 90041993 90042056 90042090 90041812 90041907 90041994 90042058 90042092 90041813 90041921 90041995 90042060 90042093 90041814 90041925 90041997 90042063 90042094 90041815 90041930 90042005 90042066 90042097
• Recalling Firm/ Manufacturer: Maquet Medical Systems USA; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Charles Ryan; 862-222-0023
• Manufacturer Reason for Recall: The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
• FDA Determined Cause: Labeling mix-ups
• Action: An Urgent Medical Device Correction Letter was sent VIA Fed-Ex 2-day delivery with signature proof of delivery to all consignees with the following instructions: Actions to be taken by the Customer: - Please examine your inventory immediately to determine if you have any affected product in your inventory. - Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE - CORRECTION RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to BubbleSensorUDI2023.cp@getinge.com or by faxing the form to 1-866-416-5299. - Affected Bubble Sensors do not need to be returned and can be used as-is. - Please forward this information to all current and potential Bubble Sensor users within your hospital / facility. - If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or call Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
• Quantity in Commerce: 274 units (70 US, 204 OUS)
• Distribution: AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.
• 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 = DTQ and Original Applicant = MAQUET CARDIOPULMONARY AG