Class 1 Device Recall QUADROXi Neonatal oxygenator

• Date Initiated by Firm: October 25, 2018
• Date Posted: November 28, 2018
• Recall Status: Terminated on June 05, 2020
• Recall Number: Z-0436-2019
• Recall Event ID: 81382
• 510(K)Number: K102464 K141432
• Product Classification: Oxygenator, cardiopulmonary bypass - Product Code DTZ
• Product: QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
• Code Information: UDI: 04037691780139; Lots: 92212343, 92214685, 92225187
• Recalling Firm/ Manufacturer: Maquet Cardiovascular Us Sales, Llc; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Allison Jean Kaplan; 973-709-7779
• Manufacturer Reason for Recall: There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, GETTINGE, sent an "URGENT MEDICAL DEVICE RECALL" notification letters dated 10/25/18 to customers. The letters described the product, problem, and actions to be taken. The customers were instructed to do the following: -Please immediately examine your inventory to determine if you have any of the QUAD ROX-i Neonatal Oxygenator with the product codes/lot numbers listed in this notice. -If you wish to use the product, please remove and do not use the enclosed reducing screw adapter 1/4" x 3/16" (Ref. No. 70104.8593). -If you do not wish to use the product as packaged, please contact Maquet/Ge tinge Customer Support at +l (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to obtain instructions on returning the affected product for a full credit. Please note that this product is no longer being offered in the United States, and therefore product replacement is not available. -Please complete and sign the attached MEDICAL DEVICE RECALL- RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Ge tinge by e-mailing a scanned copy to neoguadroxi2018@getinge.com or by f axing the form to +l (800) 859-8371. 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 Maquet Cardiopulmonary /Ge tinge representative or call the Maquet Cardiopulmonary /Ge tinge Customer Support at +l (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
• Quantity in Commerce: 490 total in US
• Distribution: Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, IA, LA, NC, and TX and countries of: Canada, Argentina, Brazil, Chile, Colombia, Mexico, Uruguay, United Arab Emirates, Belgium, Switzerland, Germany, Egypt, Spain, France, United Kingdom, Ireland, Italy, Lebanon, Netherlands, Pakistan, Portugal, Reunion, Saudi Arabia, Sweden, South Africa, Poland, Serbia, Russia, Turkey, Ukraine, China, India, Japan, Republic of Korea (South Korea), Malaysia, Thailand, and Taiwan.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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