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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Maquet Cardiovascular Us Sales, Llc: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

Agency Publication Date: April 12, 2016
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Affected Products

Product: QUADROX-i oxygenators Custom tubing packs for the oxygenator

All sizes and membrane types of QUADROX-i oxygenators, QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; BE-HMOD xxxxx, BEQ-HMO xxxxx, BEQ-HMOD xxxxx, BO-VKMO xxxxx, HMO xxxxx, HMOD xxxxx, VKMO xxxxx, X HMO xxxxx U, X HMOD 30000 U, X VKMO xxxxx U, and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating; XVIVO HMO 70100

Product: HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator

HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786

Product: Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator

BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, RF-32u.

Product: Custom Tubing Packs Custom tubing pack for oxygenators

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.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73390
Status: Resolved
Manufacturer: Maquet Cardiovascular Us Sales, Llc
Manufactured In: United States
Units Affected: 4 products (72,000 units in total)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.