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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced

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 Class 2 Device Recall Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advancedsee related information
Date Initiated by FirmJuly 11, 2019
Create DateSeptember 13, 2019
Recall Status1 Terminated 3 on December 11, 2020
Recall NumberZ-2149-2019
Recall Event ID 83336
510(K)NumberK112360 
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
ProductMaquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Code Information Lot 70131093; UDI 04037691741543
FEI Number 3008355164
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactMaryanna Krivak
973-709-7483
Manufacturer Reason
for Recall		The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.
FDA Determined
Cause 2		Under Investigation by firm
ActionUrgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers.
Quantity in Commerce54
DistributionThe products were distributed to the following US states: AR, CA, FL, GA, IA, IL, IN, KY, NC, NE, NM, NV, NY, OH, OR, TN, and WI.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTZ
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