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Class 2 Device Recall Maquet |
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Date Initiated by Firm |
February 23, 2016 |
Create Date |
April 12, 2016 |
Recall Status1 |
Terminated 3 on September 25, 2019 |
Recall Number |
Z-1374-2016 |
Recall Event ID |
73390 |
510(K)Number |
K080592
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Product Classification |
Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
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Product |
Custom Tubing Packs
Custom tubing pack for oxygenators |
Code Information |
containing products included in this action which include the following serial numbers; T xxxxx, TOP xxxxx, BE-TOP xxxxx, BO-TOP xxxxx, BO-T xxxxx, BEQ-T xxxxx, and BEQ-TOP xxxxx. |
Recalling Firm/ Manufacturer |
Maquet Cardiovascular Us Sales, Llc 45 Barbour Pond Drive Wayne NJ 07470
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Manufacturer Reason for Recall |
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
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FDA Determined Cause 2 |
Unknown/Undetermined by firm |
Action |
The firm, Maquet Inc., sent an "URGENT MEDICAL DEVICE RECALL" Letter/Response Form dated 2/23/2016 via Fed Ex to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the list to determine if you have the affected products; monitor patients for signs; monitor and treat signs according to your protocols and clinical judgments; support shock symptoms and maintain circulatory and hemodynamics per your facility's protocol and care guidelines, and complete and and return the enclosed Response Form by email to: MCPrecall2016@maquet.com or fax to: 1-973-629-1518 within three (3) business days.
For any questions, please contact your Maquet sales and representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2) Monday through Friday, between the hours of 8:00am and 6:00pm EST. |
Quantity in Commerce |
72,000 units in total |
Distribution |
US Nationwide Distribution. |
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 = KFM and Original Applicant = MAQUET CARDIOPULMONARY AG
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