Maquet Medical Systems USA: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

Agency Publication Date: May 30, 2023

Affected Products

Product: QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388

Model Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 All lots

Product: QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859

Model Item No. UDI-DI HMOD 70000-USA 701067840 4058863019000 BEQ-HMOD70000-USA 701067859 4058863019024

Product: QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895

Model Item no. UDI-DI BEQ-HMO 50000-USA 701067905 4058863019079 HMO 50000-USA 701067891 4058863019055 HMO 51000-USA 701067895 4058863019185 All lots

Product: QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330

Model Item No. UDI-DI BEQ-HMOD30000-USA 701070397 4058863154435 BEQ-HMOD30000-USA 701050330 4037691670164 All lots

Product: QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

Model Item No. UDI HMO 70000-USA 701067820 4058863019147 HMO 71000-USA 701067823 4058863017341 BEQ-HMO 71000-USA 701067829 4058863017372 All lots

Product: QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416

Model Item No. UDI HMO 10000-USA 701070412 4058863154473 HMO 11000-USA 701070416 4058863154558 All lots

Product: Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

Model Item No. UDI VKMO 10000-USA 701070441 4058863153889 VKMO 11000-USA 701070445 4058863153889 All lots

Product: QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100

Model Item No. UDI-DI BEQ-HMO 51100-USA 701067936 N/A BEQ-HMO 71100-USA 701067880 4058863164052 HMO 50100-USA 701067934 N/A HMO 51100-USA 701067938 N/A HMO 70100-USA 701067874 N/A HMO 71100-USA 701067886 N/A All lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92006

Status: Active

Manufacturer: Maquet Medical Systems USA

Manufactured In: United States

Units Affected: 8 products (0 (US); 24,250 (US); 1,784 (US); 5,022 (US); 0 (US); 0 (US); 0 (US); 0 (US))

Agency Last Updated: June 1, 2023

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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

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