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Terminated

QUADROX-i oxygenators Custom tubing packs for the oxygenator

FDA Recall Z-1371-2016 · Posted None

Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeDTZ
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.

K102464QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATINGMaquet Cardiopulmonary, AG · 2011-03-04K101153QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMODMaquet Cardiopulmonary, AG · 2010-12-08K093522QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE CMaquet Cardiopulmonary, AG · 2009-12-07K090689QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000Maquet Cardiopulmonary, AG · 2009-10-29K082117QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000Maquet Cardiopulmonary, AG · 2009-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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