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U.S. Department of Health and Human Services

Class 1 Device Recall Quadroxi Neonatal Oxygenator

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  Class 1 Device Recall Quadroxi Neonatal Oxygenator see related information
Date Initiated by Firm October 25, 2018
Date Posted November 28, 2018
Recall Status1 Terminated 3 on June 05, 2020
Recall Number Z-0437-2019
Recall Event ID 81382
510(K)Number K102464  K141432  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207

The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Code Information UDI: 04037691773414; Lots: 92209374, 92211752, 92215106, 92222131, 92223169, 92228805, 92234286, 92236876
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 2		 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 and Original Applicant = MAQUET CARDIOPULMONARY AG
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