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Class 2 Device Recall Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced |
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Date Initiated by Firm |
July 11, 2019 |
Create Date |
September 13, 2019 |
Recall Status1 |
Terminated 3 on December 11, 2020 |
Recall Number |
Z-2149-2019 |
Recall Event ID |
83336 |
510(K)Number |
K112360
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Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
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Product |
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794 |
Code Information |
Lot 70131093; UDI 04037691741543 |
Recalling Firm/ Manufacturer |
Maquet Cardiovascular Us Sales, Llc 45 Barbour Pond Dr Wayne NJ 07470-2094
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For Additional Information Contact |
Maryanna Krivak 973-709-7483
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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.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Urgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers. |
Quantity in Commerce |
54 |
Distribution |
The 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 Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DTZ and Original Applicant = MAQUET CARDIOPULMONARY AG
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