Custom Tubing Packs Custom tubing pack for oxygenators
FDA Recall Z-1374-2016 · Posted None
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Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeKFM
Date Initiated2016-02-23
Date Terminated2019-09-25
Product Quantity72,000 units in total
Reason for Recall
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
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: [email protected] 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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
US Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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