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U.S. Department of Health and Human Services

Class 2 Device Recall QUADROX i Neonatal

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  Class 2 Device Recall QUADROX i Neonatal see related information
Date Initiated by Firm May 18, 2023
Date Posted May 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-1661-2023
Recall Event ID 92006
510(K)Number K102919  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Code Information Model Item No. UDI VKMO 10000-USA 701070441 4058863153889 VKMO 11000-USA 701070445 4058863153889 All lots
Recalling Firm/
Manufacturer		 Maquet Medical Systems USA
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Maryanna Krivak
973-709-7483
Manufacturer Reason
for Recall		 Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
FDA Determined
Cause 2		 Under Investigation by firm
Action On May 18, 2023, the firm notified customers of the recall via an Urgent Medical Device Removal letter. Actions to be taken by the customer: If an affected device is already in use, please use according to normal practices. Monitor the patient for signs and symptoms of inflammation, infection, sepsis, and ischemia. If detected, treat according to clinical protocols. Please remove any affected product in inventory from areas of use. Unopened and unexpired affected product is eligible for credit upon return. Product Return: Please contact Getinge Customer Service at 1-888-943-8872 option 2 between the hours of 6:00 AM and 5:00 PM Pacific Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Distributors who have shipped affected products to customers should forward the notification to customers' attention for appropriate action. Maquet Cardiopulmonary GmbH is working with all possible urgency on the redesign and revalidation of a packaging solution, which is anticipated to be available by Q4 2023.
Quantity in Commerce 0 (US)
Distribution Nationwide domestic distribution
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 = DTZ and Original Applicant = MAQUET CARDIOPULMONARY AG
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